FDA Product Code
FDA Product Code BZD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5905
510(k) Clearances — 462 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K031064 | INVACARE POLARIS EX CPAP, MODEL ISP3000 | Invacare Corp. | 2004-03-12 | Traditional | PDF ↗ |
| K030797 | S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM | Resmed Corp | 2004-03-10 | Traditional | PDF ↗ |
| K033841 | RESMED S8 PRIME CPAP SYSTEM | Resmed, Ltd. | 2004-03-10 | Traditional | PDF ↗ |
| K032834 | BIPAP PRO 2 BI-LEVEL SYSTEM | Respironics, Inc. | 2004-03-04 | Traditional | PDF ↗ |
| K031935 | TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 | Tiara Medical Systems, Inc. | 2004-03-03 | Traditional | PDF ↗ |
| K032056 | BILEVEL CPAP, MODEL 9055 SERIES | Sunrise Medical | 2004-02-20 | Traditional | PDF ↗ |
| K033759 | C2 NASAL MASK | Respironics, Inc. | 2004-02-19 | Traditional | PDF ↗ |
| K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION | Sensor Medics Corp. | 2004-02-13 | Traditional | PDF ↗ |
| K022650 | APEX MEDICAL CPAP RT 21XX | Apex Medical Corp. | 2004-02-04 | Traditional | PDF ↗ |
| K033087 | ORACLE ORAL MASK, MODEL HC451A | Fisher & Paykel Healthcare, Ltd. | 2004-01-14 | Special | PDF ↗ |
| K032916 | MIRAGE ACTIVA MASK | Resmed, Ltd. | 2003-12-04 | Traditional | PDF ↗ |
| K023683 | MULTI-STRAP FULL FACE MASK | Engineered Medical Systems | 2003-12-01 | Traditional | PDF ↗ |
| K032433 | NASAL JACKS MASK | Resmed, Ltd. | 2003-10-24 | Traditional | PDF ↗ |
| K032480 | AUTOSET SPIRIT SYSTEM | Resmed, Ltd. | 2003-10-16 | Traditional | PDF ↗ |
| K030985 | BREAS PV 10I CPAP SYSTEM, MODEL PV 10I | Vital Signs, Inc. | 2003-10-15 | Traditional | PDF ↗ |
| K030563 | ARABELLA NCPAP MASKS | Hamilton Medical AG | 2003-09-09 | Traditional | PDF ↗ |
| K031883 | LYRA NASAL MASK | Sensor Medics Corp. | 2003-08-25 | Traditional | PDF ↗ |
| K031047 | MIRAGE VISTA MASK | Resmed, Ltd. | 2003-08-19 | Traditional | PDF ↗ |
| K030843 | VPAP III | Resmed, Ltd. | 2003-08-15 | Traditional | PDF ↗ |
| K014074 | HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION | Hoffrichter GmbH | 2003-07-23 | Traditional | PDF ↗ |
| K024191 | S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK | Resmed, Ltd. | 2003-07-02 | Traditional | PDF ↗ |
| K031460 | MODIFICATION TO REMSTAR AUTO CPAP SYSTEM | Respironics, Inc. | 2003-06-24 | Special | PDF ↗ |
| K023559 | FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK | Fisher & Paykel Healthcare, Ltd. | 2003-06-12 | Traditional | PDF ↗ |
| K023670 | SINGLE USE ORAL MASK, MODEL HC455A | Fisher & Paykel Healthcare, Ltd. | 2003-06-12 | Traditional | PDF ↗ |
| K031470 | PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US | Tyco Healthcare Nancy | 2003-06-05 | Special | PDF ↗ |
| K030822 | 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS | Hans Rudolph, Inc. | 2003-06-03 | Traditional | PDF ↗ |
| K023068 | PAPILLON MASK SET | Map Medizintechnik Fur Arzt Und Patient GmbH | 2003-05-28 | Traditional | PDF ↗ |
| K030798 | MIRAGE ACTIVA MASK | Resmed, Ltd. | 2003-04-09 | Special | PDF ↗ |
| K022465 | MODIFICATION TO NASAL-AIRE | Innomed Technologies | 2003-03-21 | Traditional | PDF ↗ |
| K022642 | TWLIGHT, MODEL ISP 9600 | Invacare Corp. | 2003-02-11 | Traditional | PDF ↗ |
| K022192 | PEGASUS NASAL CPAP SYSTEM | Sensor Medics Corp. | 2003-01-24 | Traditional | PDF ↗ |
| K023306 | MIRAGE FULL FACE MASK SERIES 2 | Resmed, Ltd. | 2002-11-27 | Traditional | PDF ↗ |
| K023244 | MIRAGE FULL FACE MASK SERIES 2 | Resmed, Ltd. | 2002-11-27 | Traditional | PDF ↗ |
| K023284 | MIRAGE FULL FACE MASK SERIES 2 | Resmed, Ltd. | 2002-11-27 | Traditional | PDF ↗ |
| K022934 | SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650 | Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits | 2002-11-14 | Traditional | PDF ↗ |
| K020886 | PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US | Tyco Healthcare Nancy | 2002-11-01 | Abbreviated | PDF ↗ |
| K020641 | SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 | Worldwide Medical Technologies, LLC | 2002-10-29 | Traditional | PDF ↗ |
| K020759 | 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT | Hans Rudolph, Inc. | 2002-08-13 | Traditional | PDF ↗ |
| K013843 | AUTOSET SPIRIT CPAP SYSTEM | Resmed Corp | 2002-07-16 | Traditional | PDF ↗ |
| K013909 | S7 ELITE CP AP SYSTEM | Resmed Corp | 2002-07-08 | Traditional | PDF ↗ |
| K021534 | IQ NASAL MASK, MODEL 50160 REV. D | Sleepnet Corporation | 2002-07-02 | Special | PDF ↗ |
| K021861 | REMSTAR PRO WITH C-FLEX CPAP SYSTEM | Respironics, Inc. | 2002-06-19 | Special | PDF ↗ |
| K020730 | ORION NASAL CPAP SYSTEM | Bird Products Corp. | 2002-05-22 | Special | PDF ↗ |
| K012554 | REMSTAR AUTO CPAP SYSTEM | Respironics, Inc. | 2002-01-29 | Special | PDF ↗ |
| K013738 | WEINMANN SOMNOMASK | Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits | 2002-01-22 | Traditional | PDF ↗ |
| K013421 | LIFEGUARD NASAL CPAP MASK AND ACCESSORIES | Lifeguard Medical Products, Inc. | 2002-01-08 | Traditional | PDF ↗ |
| K013306 | MINIME NASAL MASK, MODEL P/N 50220 | Sleepnet Corporation | 2001-11-02 | Special | PDF ↗ |
| K012034 | MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT | Sensor Medics Corp. | 2001-07-24 | Special | PDF ↗ |
| K012207 | ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 | Tiara Medical Systems, Inc. | 2001-07-23 | Special | PDF ↗ |
| K011229 | DEVILBISS 9000 SERIES CPAP, MODEL 9001 | Sunrise Medical Hhg, Inc. | 2001-07-11 | Special | PDF ↗ |
| K011714 | BIPAP PRO BI-LEVEL SYSTEM | Respironics, Inc. | 2001-06-28 | Special | PDF ↗ |
| K003894 | ORACLE ORAL MASK | Fisher & Paykel Healthcare, Ltd. | 2001-06-25 | Traditional | PDF ↗ |
| K011516 | INFANT FLOW SYSTEM, MODEL M672P | Eme (Electro Medical Equipment) , Ltd. | 2001-06-08 | Traditional | PDF ↗ |
| K002763 | REMREST | Medical Industries America, Inc. | 2001-05-04 | Traditional | PDF ↗ |
| K010704 | DORNIR LC-1 CPAP SYSTEM | Prym Medical , Ltd. | 2001-04-18 | Special | PDF ↗ |
| K010263 | REMSTAR PLUS CPAP SYSTEM | Respironics, Inc. | 2001-03-29 | Traditional | PDF ↗ |
| K993094 | AERO-CLICK | Map Medizintechnik Fur Arzt Und Patient GmbH | 2000-10-23 | Traditional | PDF ↗ |
| K002465 | SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 | Respironics, Inc. | 2000-09-08 | Special | PDF ↗ |
| K000705 | RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 | Respironics, Inc. | 2000-09-08 | Abbreviated | PDF ↗ |
| K002001 | BREEZE SLEEPGEAR WITH DREAMSEAL | Puritan Bennett Corp. | 2000-09-06 | Special | PDF ↗ |
| K000888 | SANSIBAR CPAP SYSTEM | Prym Medical , Ltd. | 2000-08-15 | Traditional | PDF ↗ |
| K001553 | BREAS PV 100 CPAP SYSTEM | Vital Signs, Inc. | 2000-08-03 | Traditional | PDF ↗ |
| K001845 | MALLINCKRODT, GOODKNIGHT 418S | Mallinckrodt Developpement France | 2000-07-05 | Special | PDF ↗ |
| K000994 | BIPAP DUET LX BI-LEVEL SYSTEM | Respironics, Inc. | 2000-06-22 | Special | PDF ↗ |
| K000215 | SWIVEL ELBOW | Engineered Medical Systems | 2000-05-26 | Traditional | PDF ↗ |
| K992192 | AIRPILOTMASK, MODEL TMS-900 | Tiara Medical Systems, Inc. | 2000-05-12 | Traditional | PDF ↗ |
| K993584 | MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 | Nellcor Puritan Bennett France Dvpt. | 2000-03-07 | Abbreviated | PDF ↗ |
| K990856 | HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 | Bird Products Corp. | 2000-01-11 | Traditional | PDF ↗ |
| K992384 | CPAP/PRO CPAP INTERFACE | Stevenson Industries, Inc. | 1999-12-01 | Traditional | PDF ↗ |
| K990659 | NASAL AIRE | Breathing Technologies Corp. | 1999-11-26 | Traditional | PDF ↗ |
| K992969 | RESPIRONICS TOTAL FACE MASK | Respironics, Inc. | 1999-11-10 | Special | PDF ↗ |
| K993433 | VIRTUOSO LX SMART CPAP SYSTEM | Respironics, Inc. | 1999-10-27 | Special | PDF ↗ |
| K993269 | IQ NASAL MASK, MODEL P/N 50160 | Sleepnet Corporation | 1999-10-27 | Special | PDF ↗ |
| K993307 | ARIA LX CPAP SYSTEM | Respironics, Inc. | 1999-10-27 | Special | PDF ↗ |
| K991926 | OPAP | Opap, Inc. | 1999-10-18 | Traditional | PDF ↗ |
| K991972 | INFANT FLOW SYSTEM | Sensor Medics Corp. | 1999-08-13 | Special | PDF ↗ |
| K992336 | MONARCH II MINI MASK | Respironics, Inc. | 1999-08-13 | Special | PDF ↗ |
| K984428 | SULLIVAN AUTOSET NASAL CPAP SYSTEM | Resmed, Ltd. | 1999-07-26 | Traditional | PDF ↗ |
| K991648 | REUSABLE CONTOUR II NASAL MASK | Respironics, Inc. | 1999-05-28 | Special | PDF ↗ |
| K991150 | NELLCOR PURITAN BENNETT, GOODKNIGHT 418G | Nellcor Puritan Bennett France Dvpt. | 1999-04-14 | Special | PDF ↗ |
| K984254 | INFANT FLOW NCPAP MASKS | Sensor Medics Corp. | 1999-02-24 | Traditional | PDF ↗ |
| K982242 | INVACARE CPAP | Invacare Corp. | 1999-01-27 | Traditional | PDF ↗ |
| K980551 | SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | Nidek Medical Products, Inc. | 1998-11-17 | Traditional | PDF ↗ |
| K982530 | SULLIVAN MIRAGE FULL FACE MASK | Resmed, Ltd. | 1998-10-16 | Traditional | PDF ↗ |
| K981744 | COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER | W. Keith Thornton, D.D.S. | 1998-10-14 | Traditional | PDF ↗ |
| K980721 | SULLIVAN AUTOSET | Resmed, Ltd. | 1998-09-01 | Traditional | PDF ↗ |
| K974453 | NASAL INTERFACE MODEL 7910 | Healthdyne Technologies, Inc. | 1998-08-04 | Traditional | PDF ↗ |
| K980365 | GOODKNIGHT 418 CPAP SYSTEM | Nellcor Puritan Bennett, Inc. | 1998-07-22 | Traditional | PDF ↗ |
| K973161 | CPAP HUMIDIFIER (HC 200) | Fisher & Paykel Electronics , Ltd. | 1998-07-10 | Traditional | PDF ↗ |
| K974879 | MODEL 7410 VOYAGER | Healthdyne Technologies, Inc. | 1998-06-29 | Traditional | PDF ↗ |
| K974303 | INFANT FLOW SYSTEM | Sensor Medics Corp. | 1998-01-30 | Traditional | PDF ↗ |
| K972605 | EMS NASAL CPAP MASK | Engineered Medical Systems | 1998-01-28 | Traditional | PDF ↗ |
| K964092 | TMS COMFORT SERIES NASAL CPAP MASK | Tiara Medical Systems, Inc. | 1997-07-31 | Traditional | PDF ↗ |
| K970771 | SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM | Resmed, Ltd. | 1997-06-20 | Traditional | PDF ↗ |
| K964019 | MORPHEE PLUS ALPHA | Nellcor Puritan Bennett, Inc. | 1997-06-18 | Traditional | PDF ↗ |
| K970516 | SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM | Resmed, Ltd. | 1997-05-09 | Traditional | PDF ↗ |
| K963761 | QUARTET CLINICAL SYSTEM | Respironics, Inc. | 1997-04-18 | Traditional | PDF ↗ |
| K970173 | MODEL 1700 TRANQUILITY BILEVEL SYSTEM | Healthdyne Technologies, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K951944 | NASALFLAIR | Airways Ltd., Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K964363 | BIPAP DUET SYSTEM | Respironics, Inc. | 1997-01-30 | Traditional | PDF ↗ |
Product code BZD · Class II · Anesthesiology. Data: openFDA.