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 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K962203 | WHISPER SWIVEL II EXHALATION PORT | Respironics, Inc. | 1996-12-05 | Traditional | PDF ↗ |
| K963250 | PRESSURE VALVE | Respironics, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K962713 | DPAP STEALTH SLEEPNET MODEL NUMBER 84000 | Sleepnet Corporation | 1996-10-23 | Traditional | PDF ↗ |
| K953930 | VIRTUOSO SMART CPAP SYSTEM | Respironics, Inc. | 1996-09-30 | Traditional | PDF ↗ |
| K961915 | SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE | Respironics, Inc. | 1996-08-15 | Traditional | PDF ↗ |
| K961783 | SULLIVAN VPAP II ST NASAL VPAP SYSTEM | Resmed, Ltd. | 1996-08-01 | Traditional | PDF ↗ |
| K943207 | NITELIFE BI-LEVEL CPAP | Airsep Corp. | 1996-07-29 | Traditional | PDF ↗ |
| K961626 | SOLO CPAP SYSTEM | Respironics, Inc. | 1996-07-18 | Traditional | PDF ↗ |
| K952429 | RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM | Rescare , Ltd. | 1996-07-02 | Traditional | PDF ↗ |
| K954572 | MAESTRO CLINICAL REMOTE CONTROL | Respironics, Inc. | 1996-06-26 | Traditional | PDF ↗ |
| K953697 | THE IMS DPAP MASK, IMS MODEL NUMBER 82000 | Sleepnet Corporation | 1996-06-13 | Traditional | PDF ↗ |
| K952475 | SULLIVAN NOSE & MOUTH MASK SYSTEM | Rescare , Ltd. | 1996-05-28 | Traditional | PDF ↗ |
| K960518 | THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM | Puritan Bennett Corp. | 1996-05-09 | Traditional | PDF ↗ |
| K952966 | CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | Nidek Medical Products, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K950849 | MODEL #7354 | Devilbiss Health Care, Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K954207 | GEL MASK | Respironics, Inc. | 1996-01-31 | Traditional | PDF ↗ |
| K952491 | MODEL 7355 | Devilbiss Health Care, Inc. | 1996-01-31 | Traditional | PDF ↗ |
| K945938 | RESPIRONICS MONARCH MINI MASK | Respironics, Inc. | 1996-01-31 | Traditional | PDF ↗ |
| K953341 | ARIA CPAP SYSTEM | Respironics, Inc. | 1996-01-30 | Traditional | PDF ↗ |
| K952292 | PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM | Puritan Bennett Corp. | 1995-11-13 | Traditional | PDF ↗ |
| K950331 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) | Healthdyne, Inc. | 1995-09-21 | Traditional | PDF ↗ |
| K936047 | SPECTRUM(TM) MASK | Respironics, Inc. | 1995-03-29 | Traditional | PDF ↗ |
| K934804 | PURITAN-BENNETT COMPANION 320 I/E | Puritan Bennett Corp. | 1995-02-27 | Traditional | PDF ↗ |
| K933184 | POSITIVE AIRWAY PRESSURE SYSTEM | Innovative Medical Systems, Inc. | 1994-11-28 | Traditional | PDF ↗ |
| K935979 | CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM | Devilbiss Health Care, Inc. | 1994-11-10 | Traditional | PDF ↗ |
| K933947 | LIFECARE CPAP-200 | Lifecare International,Inc. | 1994-11-10 | Traditional | PDF ↗ |
| K943509 | 7300 NASAL CPAP SYSTEM | Healthdyne Technologies, Inc. | 1994-08-05 | Traditional | PDF ↗ |
| K935784 | PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM | Puritan-Bennett | 1994-07-13 | Traditional | PDF ↗ |
| K931884 | SULLIVAN NASAL VPAP SYSTEM | Rescare , Ltd. | 1994-06-07 | Traditional | PDF ↗ |
| K930656 | SULLIVAN III NASAL CPAP SYSTEM | Rescare , Ltd. | 1994-03-15 | Traditional | PDF ↗ |
| K931484 | REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S | Portable Power Systems, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K925587 | NASAL/ORAL MASK | Respironics, Inc. | 1993-09-14 | Traditional | PDF ↗ |
| K925920 | TOTAL FACE MASK | Respironics, Inc. | 1993-07-21 | Traditional | PDF ↗ |
| K923590 | 318A RESPIRATORY SUPPORT SYSTEM | Puritan Bennett Corp. | 1993-04-09 | Traditional | PDF ↗ |
| K920699 | REMSTAR WTIH RAMP AND REMOTE MODIFICATION | Respironics, Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K911465 | INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL | Vital Signs, Inc. | 1991-10-18 | Traditional | PDF ↗ |
| K912224 | LIFECARE CPAP-100 | Lifecare Services, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K911856 | RESPIRONICS REMSTAR WITH REMOTE AND RAMP | Respironics, Inc. | 1991-08-09 | Traditional | PDF ↗ |
| K912434 | SALTER LABS INFANT NASAL CPAP CANNULA | Salter Labs | 1991-07-30 | Traditional | PDF ↗ |
| K911780 | INFANT NASAL CANNULAE ASSEMBLY, MODIFIED | Ackrad Laboratories | 1991-06-24 | Traditional | PDF ↗ |
| K905404 | MEDTRONIC SULLIVAN NASAL CPAP SYSTEM | Medtronic Vascular | 1991-05-13 | Traditional | PDF ↗ |
| K910194 | COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM | Puritan Bennett Corp. | 1991-05-13 | Traditional | PDF ↗ |
| K904344 | SLEEPER MASK SYSTEM | Devilbiss Health Care, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K905593 | SLEEPAP | Medical Industries America, Inc. | 1991-04-23 | Traditional | PDF ↗ |
| K904766 | DEVILBISS MODEL 7352 SERIES | Devilbiss Health Care, Inc. | 1991-03-26 | Traditional | PDF ↗ |
| K905540 | RESPIRONICS BIPAP REMOTE CONTROL UNIT | Respironics, Inc. | 1991-01-30 | Traditional | PDF ↗ |
| K895031 | MODIFIED INFANT NASAL CANNULAE ASSEMBLY | Ackrad Laboratories | 1989-10-30 | Traditional | PDF ↗ |
| K871351 | H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP | Holter-Hausner Intl. | 1987-05-14 | Traditional | PDF ↗ |
| K871157 | C.P.A.P. NASAL CANNULA | Hudson Oxygen Therapy Sales Co. | 1987-04-21 | Traditional | PDF ↗ |
| K864883 | NEONATAL CANNULA CAP | Behan & Taylor Ent. | 1987-01-28 | Traditional | PDF ↗ |
| K863746 | BIRD NIGHTBIRD NASAL CPAP SYSTEM | Bird Products Corp. | 1986-12-15 | Traditional | PDF ↗ |
| K862448 | FLOW GENERATOR FOR SLEEP APNEA, LDS 1500 | Life Design Systems, Inc. | 1986-11-14 | Traditional | PDF ↗ |
| K861555 | CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT | Respiratory Care, Inc. | 1986-06-05 | Traditional | PDF ↗ |
| K861280 | MEDICOMP CPAP NASAL CANNULA | Medicomp, Inc. | 1986-05-09 | Traditional | PDF ↗ |
| K853487 | PATIENT BREATHING CIRCUIT | Infrasonics Corp. | 1985-09-06 | Traditional | PDF ↗ |
| K852821 | DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT) | Puritan Bennett Corp. | 1985-07-29 | Traditional | PDF ↗ |
| K841773 | INFANT NASAL CANNULAE ASSEMBLY | Ackrad Laboratories | 1984-07-26 | Traditional | PDF ↗ |
| K823936 | CPAP INFANT NASAL CANNULAE SET | Ackrad Laboratories | 1983-01-28 | Traditional | PDF ↗ |
| K813075 | TRITEC DOC TM | Tri-Tech, Inc. | 1981-12-09 | Traditional | PDF ↗ |
| K811409 | ARGYLE CPAP NASAL CANNULA | Sherwood Medical Co. | 1981-06-02 | Traditional | PDF ↗ |
| K792722 | NOVAMETRIX CPAP NASAL CANNULA | Novametrix Medical Systems, Inc. | 1980-01-24 | Traditional | PDF ↗ |
| K771217 | ANESTHESIA RESPIRATOR | Rule Medical Instruments, Inc. | 1977-08-04 | Traditional | PDF ↗ |
Product code BZD · Class II · Anesthesiology. Data: openFDA.