FDA Product Code
FDA Product Code MNR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.2375
510(k) Clearances — 165 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072201 | COMPUMEDICS SOMTE PSG RECORDING SYSTEM | Compumedics Limited | 2008-04-14 | Traditional | PDF ↗ |
| K070855 | SLEEP QUALITY | Dynadx Corporation | 2008-03-20 | Traditional | PDF ↗ |
| K072014 | VITASCORE | Vitascore B.V. | 2007-11-08 | Traditional | PDF ↗ |
| K071230 | APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 | Advanced Brain Monitoring, Inc. | 2007-10-03 | Special | PDF ↗ |
| K071556 | SOMNOSCREEN EEG10-20 | Somnomedics GmbH | 2007-07-18 | Special | PDF ↗ |
| K070263 | APNEALINK | Resmed Germany, Inc. | 2007-06-15 | Traditional | PDF ↗ |
| K070326 | NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM | Widemed, Ltd. | 2007-05-05 | Traditional | PDF ↗ |
| K060708 | SOMNOSCREEN | Somnomedics GmbH & Co. KG | 2007-01-24 | Traditional | PDF ↗ |
| K061705 | CADWELL EASYNET NASAL PRESSURE MODULE | Cadwell Laboratories, Inc. | 2006-11-21 | Traditional | PDF ↗ |
| K061996 | SANDMAN POCKET | Eb Neuro S.P.A. | 2006-10-03 | Traditional | PDF ↗ |
| K061764 | MEDIBYTE, MODEL MP8 | Braebon Medical Corp. | 2006-09-06 | Traditional | PDF ↗ |
| K061405 | APNEALINK, MODEL 22302 | Resmed Germany, Inc. | 2006-07-25 | Traditional | PDF ↗ |
| K052573 | STARDUST II | Respironics, Inc. | 2005-12-13 | Traditional | PDF ↗ |
| K051313 | BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER | Salter Labs | 2005-09-15 | Traditional | PDF ↗ |
| K042745 | LIFESCREEN APNEA | Del Mar Reynolds Medical, Inc. | 2005-01-19 | Traditional | PDF ↗ |
| K042916 | WATCH PAT 100S | Itamar Medical | 2004-12-29 | Traditional | PDF ↗ |
| K043132 | UNIVERSAL XACTTRACE | Medcare Flaga | 2004-12-21 | Traditional | PDF ↗ |
| K041662 | APNEA RISK EVALUATION SYSTEM (ARES) | Advanced Brain Monitoring, Inc. | 2004-10-14 | Traditional | PDF ↗ |
| K042253 | SLEEPSENSE SLEEP SENSORS | S.L.P. , Ltd. | 2004-10-06 | Traditional | PDF ↗ |
| K041724 | COMPASS M10 SYSTEM | Medcare Flaga | 2004-09-28 | Traditional | PDF ↗ |
| K041904 | COMPASS F10 SYSTEM | Medcare Flaga | 2004-09-07 | Traditional | PDF ↗ |
| K040576 | MICROMESAM BASIC-SET | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004-07-01 | Traditional | PDF ↗ |
| K033402 | PORTABLE SLEEP DATA RECORDER (PSDR) | Pro-Tech Services, Inc. | 2004-06-30 | Traditional | PDF ↗ |
| K021845 | STARDUST II, MODEL 1011176 | Respironics, Inc. | 2004-05-20 | Traditional | PDF ↗ |
| K040069 | DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR | Dymedix, Inc. | 2004-05-05 | Traditional | PDF ↗ |
| K040194 | COMPUMEDICS SUMMIT IP | Compumedics USA, Ltd. | 2004-04-23 | Traditional | PDF ↗ |
| K024322 | EMBLA N7000 | Medcare Flaga | 2003-10-27 | Traditional | PDF ↗ |
| K030379 | APLAB, MODEL 801D0030 | Sector Medical Corp. | 2003-08-29 | Traditional | PDF ↗ |
| K022506 | MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM | Widemed, Ltd. | 2003-05-15 | Traditional | PDF ↗ |
| K022294 | APNEACHECK | Im Systems | 2003-04-25 | Traditional | PDF ↗ |
| K030611 | MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM | Nellcor Puritan Bennett (Melville) , Ltd. | 2003-03-24 | Special | PDF ↗ |
| K021138 | SLEEPSCREEN/APNOESCREEN CARDIO | Erich Jaeger GmbH | 2003-02-12 | Traditional | PDF ↗ |
| K021176 | COMPUMEDICS SOMTE SYSTEM | Compumedics Limited | 2003-01-21 | Traditional | PDF ↗ |
| K020607 | SLEEPFLO, MODEL 101501 | Biomec, Inc. | 2002-08-30 | Abbreviated | PDF ↗ |
| K020312 | ULTIMA SNORING MIKE, MODEL 0540 | Braebon Medical Corp. | 2002-08-07 | Traditional | PDF ↗ |
| K012437 | DEVILBISS SLEEP RECORDER MODEL # RM60 | Sunrise Medical Hhg, Inc. | 2002-07-16 | Traditional | PDF ↗ |
| K002159 | SNORE SAT RECORDER, MODEL SS41 | Sagatech Electronics, Inc. | 2002-06-28 | Traditional | PDF ↗ |
| K010156 | SLEEP PAT 200 DEVICE | Itamar Medical (C.M.) 1997 , Ltd. | 2002-06-19 | Traditional | PDF ↗ |
| K013905 | MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS | Pro-Tech Services, Inc. | 2002-04-22 | Special | PDF ↗ |
| K010739 | WATCH-PAT 100 | Itamar Medical (C.M.) 1997 , Ltd. | 2001-11-06 | Traditional | PDF ↗ |
| K002095 | SNAP MODEL 6 | Snap Laboratories, LLC | 2001-03-02 | Traditional | PDF ↗ |
| K000396 | APNOESCREEN PRO, ALPHA SCREEN PRO | Erich Jaeger, Inc. | 2000-12-27 | Traditional | PDF ↗ |
| K002135 | SLEEPSTRIP DISPOSABLE APNEA SCREENER | Influent , Ltd. | 2000-12-06 | Traditional | PDF ↗ |
| K000253 | SILENT NIGHT V | Sleep Solutions, Inc. | 2000-11-16 | Traditional | PDF ↗ |
| K992322 | SNAP MODEL 5 | Snap Laboratories, LLC | 2000-02-02 | Traditional | PDF ↗ |
| K990565 | SUZANNE | Nellcor Puritan Bennett, Inc. | 1999-08-18 | Traditional | PDF ↗ |
| K990321 | ALPHAMED GEMINI SENSOR, SNORING SENSOR | Alphamed, Inc. | 1999-06-01 | Traditional | PDF ↗ |
| K984169 | DIGI-SNAP | Snap Laboratories, LLC | 1999-05-26 | Traditional | PDF ↗ |
| K990199 | SMARTRECORDER, MODEL 2500 | Respironics, Inc. | 1999-04-19 | Traditional | PDF ↗ |
| K983572 | SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 | Healthdyne Technologies, Inc. | 1999-03-19 | Traditional | PDF ↗ |
| K981034 | SILENT NIGHT II | Sleep Solutions, Inc. | 1998-10-30 | Traditional | PDF ↗ |
| K982293 | PRESSURE TRANSDUCER AIRFLOW SENSOR | Pro-Tech Services, Inc. | 1998-07-13 | Special | PDF ↗ |
| K973920 | STARDUST | Respironics, Inc. | 1998-05-14 | Traditional | PDF ↗ |
| K971803 | NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 | Neurotronics, Inc. | 1997-11-12 | Traditional | PDF ↗ |
| K971501 | SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER | Bio-Logic Systems Corp. | 1997-10-14 | Traditional | PDF ↗ |
| K971184 | OXI-SNAP | Snap Laboratories, LLC | 1997-10-01 | Traditional | PDF ↗ |
| K955841 | SLEEP SYSTEM FOR CLINICS & RESEARCH | Compumedics Ptd , Ltd. | 1997-03-11 | Traditional | PDF ↗ |
| K964494 | SLEEPWIZARD | Nellcor Puritan Bennett, Inc. | 1997-02-04 | Traditional | PDF ↗ |
| K963597 | SILENT NIGHT I | Local Silence, Inc. | 1997-01-23 | Traditional | PDF ↗ |
| K962103 | BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER | Bio-Logic Systems Corp. | 1996-08-22 | Traditional | PDF ↗ |
| K944524 | SNAP TESTING DEVICE | Snap Laboratories, LLC | 1995-10-26 | Traditional | PDF ↗ |
| K950273 | SLEEP TEST(TM) | Cns, Inc. | 1995-09-19 | Traditional | PDF ↗ |
| K940013 | BODY POSITION INDICATOR, MODEL BPI1 | Pro-Tech, Inc. | 1995-05-04 | Traditional | PDF ↗ |
| K944611 | MODEL# 7500 SURVEYOR | Devilbiss Health Care, Inc. | 1995-04-21 | Traditional | PDF ↗ |
| K940015 | SNORING MICROPHONE, SM1 | Pro-Tech, Inc. | 1995-01-11 | Traditional | PDF ↗ |
Product code MNR · Class II · Anesthesiology. Data: openFDA.