Panels › Anesthesiology › Product code MNR · Class 2
Ventilatory Effort Recorder
Regulation 868.2375
6510(k)s in 12 months (165 all time)
1recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in MNR
| Company | 510(k)s | Recalls |
|---|---|---|
| Itamar Medical | 15 | 0 |
| Respironics, Inc. | 6 | 2 |
| Advanced Brain Monitoring | 6 | 0 |
| Snap Laboratories, LLC | 6 | 0 |
| Compumedics Limited | 5 | 0 |
| Embla Systems | 5 | 0 |
| Resmed Germany, Inc. | 5 | 0 |
| Huxley Medical | 4 | 0 |
| Medcare Flaga | 4 | 0 |
| Somnomedics GmbH | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 2008 | K072201 | COMPUMEDICS SOMTE PSG RECORDING SYSTEM Compumedics Limited, AU | MNR |
| Mar 20, 2008 | K070855 | SLEEP QUALITY Dynadx Corporation | MNR |
| Nov 8, 2007 | K072014 | VITASCORE Vitascore B.V., NL | MNR |
| Oct 3, 2007 | K071230 | APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 Advanced Brain Monitoring, Inc. | MNR |
| Jul 18, 2007 | K071556 | SOMNOSCREEN EEG10-20 Somnomedics GmbH | MNR |
| Jun 15, 2007 | K070263 | APNEALINK Resmed Germany, Inc. | MNR |
| May 5, 2007 | K070326 | NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM Widemed, Ltd., IL | MNR |
| Jan 24, 2007 | K060708 | SOMNOSCREEN Somnomedics GmbH & Co. KG | MNR |
| Nov 21, 2006 | K061705 | CADWELL EASYNET NASAL PRESSURE MODULE Cadwell Laboratories, Inc. | MNR |
| Oct 3, 2006 | K061996 | SANDMAN POCKET Eb Neuro S.P.A. | MNR |
| Sep 6, 2006 | K061764 | MEDIBYTE, MODEL MP8 Braebon Medical Corp., CA | MNR |
| Jul 25, 2006 | K061405 | APNEALINK, MODEL 22302 Resmed Germany, Inc. | MNR |
| Dec 13, 2005 | K052573 | STARDUST II Respironics, Inc. | MNR |
| Sep 15, 2005 | K051313 | BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER Salter Labs | MNR |
| Jan 19, 2005 | K042745 | LIFESCREEN APNEA Del Mar Reynolds Medical, Inc. | MNR |
| Dec 29, 2004 | K042916 | WATCH PAT 100S Itamar Medical | MNR |
| Dec 21, 2004 | K043132 | UNIVERSAL XACTTRACE Medcare Flaga, IS | MNR |
| Oct 14, 2004 | K041662 | APNEA RISK EVALUATION SYSTEM (ARES) Advanced Brain Monitoring, Inc. | MNR |
| Oct 6, 2004 | K042253 | SLEEPSENSE SLEEP SENSORS S.L.P. , Ltd., IL | MNR |
| Sep 28, 2004 | K041724 | COMPASS M10 SYSTEM Medcare Flaga, IS | MNR |
| Sep 7, 2004 | K041904 | COMPASS F10 SYSTEM Medcare Flaga, IS | MNR |
| Jul 1, 2004 | K040576 | MICROMESAM BASIC-SET Map Medizintechnik Fur Arzt Und Patient GmbH | MNR |
| Jun 30, 2004 | K033402 | PORTABLE SLEEP DATA RECORDER (PSDR) Pro-Tech Services, Inc. | MNR |
| May 20, 2004 | K021845 | STARDUST II, MODEL 1011176 Respironics, Inc. | MNR |
| May 5, 2004 | K040069 | DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR Dymedix, Inc. | MNR |
| Apr 23, 2004 | K040194 | COMPUMEDICS SUMMIT IP Compumedics USA, Ltd. | MNR |
| Oct 27, 2003 | K024322 | EMBLA N7000 Medcare Flaga | MNR |
| Aug 29, 2003 | K030379 | APLAB, MODEL 801D0030 Sector Medical Corp. | MNR |
| May 15, 2003 | K022506 | MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM Widemed, Ltd., IL | MNR |
| Apr 25, 2003 | K022294 | APNEACHECK Im Systems | MNR |
| Mar 24, 2003 | K030611 | MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM Nellcor Puritan Bennett (Melville) , Ltd., CA | MNR |
| Feb 12, 2003 | K021138 | SLEEPSCREEN/APNOESCREEN CARDIO Erich Jaeger GmbH | MNR |
| Jan 21, 2003 | K021176 | COMPUMEDICS SOMTE SYSTEM Compumedics Limited | MNR |
| Aug 30, 2002 | K020607 | SLEEPFLO, MODEL 101501 Biomec, Inc. | MNR |
| Aug 7, 2002 | K020312 | ULTIMA SNORING MIKE, MODEL 0540 Braebon Medical Corp., CA | MNR |
| Jul 16, 2002 | K012437 | DEVILBISS SLEEP RECORDER MODEL # RM60 Sunrise Medical Hhg, Inc. | MNR |
| Jun 28, 2002 | K002159 | SNORE SAT RECORDER, MODEL SS41 Sagatech Electronics, Inc., CA | MNR |
| Jun 19, 2002 | K010156 | SLEEP PAT 200 DEVICE Itamar Medical (C.M.) 1997 , Ltd. | MNR |
| Apr 22, 2002 | K013905 | MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS Pro-Tech Services, Inc. | MNR |
| Nov 6, 2001 | K010739 | WATCH-PAT 100 Itamar Medical (C.M.) 1997 , Ltd. | MNR |
| Mar 2, 2001 | K002095 | SNAP MODEL 6 Snap Laboratories, LLC | MNR |
| Dec 27, 2000 | K000396 | APNOESCREEN PRO, ALPHA SCREEN PRO Erich Jaeger, Inc. | MNR |
| Dec 6, 2000 | K002135 | SLEEPSTRIP DISPOSABLE APNEA SCREENER Influent , Ltd. | MNR |
| Nov 16, 2000 | K000253 | SILENT NIGHT V Sleep Solutions, Inc. | MNR |
| Feb 2, 2000 | K992322 | SNAP MODEL 5 Snap Laboratories, LLC | MNR |
| Aug 18, 1999 | K990565 | SUZANNE Nellcor Puritan Bennett, Inc. | MNR |
| Jun 1, 1999 | K990321 | ALPHAMED GEMINI SENSOR, SNORING SENSOR Alphamed, Inc. | MNR |
| May 26, 1999 | K984169 | DIGI-SNAP Snap Laboratories, LLC | MNR |
| Apr 19, 1999 | K990199 | SMARTRECORDER, MODEL 2500 Respironics, Inc. | MNR |
| Mar 19, 1999 | K983572 | SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 Healthdyne Technologies, Inc. | MNR |
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