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 |
|---|---|---|---|
| Nov 21, 2018 | K181996 | MATRx Plus Zephyr Sleep Technologies, CA | MNR |
| Aug 17, 2018 | K180775 | Watch-PAT300 Itamar Medical , Ltd., IL | MNR |
| Mar 9, 2018 | K172799 | Positional Sleep Assessment System (PoSAS) software Advanced Brain Monitoring | MNR |
| Oct 13, 2017 | K163696 | SleepImage System Mycardio, LLC Dba Sleepimage. | MNR |
| May 5, 2017 | K163665 | MATRx plus Zephyr Sleep Technologies, CA | MNR |
| Apr 24, 2017 | K160499 | Apnea Risk Evaluation System (ARES), Model 620 Watermark Medical | MNR |
| Feb 24, 2017 | K161579 | Watch-PAT200U Itamar Medical , Ltd., IL | MNR |
| Jul 26, 2016 | K153070 | Watch-PAT200U Itamar Medical , Ltd., IL | MNR |
| Apr 15, 2016 | K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Salter Labs | MNR |
| Mar 18, 2016 | K151433 | AUDICOR CA300/CC100 Analyzer with SDB Inovise Medical, Inc. | MNR |
| Nov 6, 2015 | K151361 | Nox RIP Belts & Cables Nox Medical Ehf, IS | MNR |
| Nov 5, 2015 | K150102 | SnoreSounds Appian Medical, Inc. | MNR |
| Apr 30, 2015 | K143272 | ApneaLink Air Resmed Germany, Inc., DE | MNR |
| Jan 30, 2015 | K140861 | SOMNOTOUCH RESP Somnomedics GmbH, DE | MNR |
| May 30, 2014 | K133859 | WATCH-PAT200U (WP200U) Itamar Medical , Ltd. | MNR |
| Apr 11, 2014 | K131883 | AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) Inovise Medical, Inc. | MNR |
| Nov 8, 2013 | K131932 | APNEALINK PRO Resmed Germany, Inc., DE | MNR |
| Oct 17, 2013 | K131994 | SOMNOLYZER 24X7 Respironics, Inc. | MNR |
| Jul 10, 2013 | K124062 | QDC-PRO, AND NOX-RIP Nox Medical, IS | MNR |
| Feb 21, 2013 | K122516 | EMBLETTA MPR Embla Systems, CA | MNR |
| Jan 9, 2012 | K112514 | APNEA RISK EVALUATION SYSTEM (ARES) Advanced Brain Monitoring, Inc. | MNR |
| Dec 27, 2011 | K112822 | SLEEPSTRIP II S.L.P. , Ltd., IL | MNR |
| Dec 20, 2011 | K112102 | MICHELE SLEEP SCORING SYSTEMS Younes Sleep Technologies, CA | MNR |
| Aug 31, 2011 | K111742 | MDRIVE Embla Systems | MNR |
| Aug 31, 2011 | K111314 | MORPHEUS OX Widemed, Ltd., IL | MNR |
| Aug 12, 2011 | K110486 | ACCUSOM Novasom, Inc. | MNR |
| Jul 7, 2011 | K111194 | APNEA RISK EVALUATION SYSTEM (ARES) Advanced Brain Monitoring, Inc. | MNR |
| Jun 2, 2011 | K102567 | WATCH-PAT 200S-3 (WP200S-3) Itamar Medical , Ltd. | MNR |
| Apr 14, 2011 | K110705 | APNEA RISK EVALUATION SYSTEM (ARES) Advanced Brain Monitoring, Inc. | MNR |
| Mar 18, 2011 | K110064 | SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM Snap Diagnostics, LLC | MNR |
| Sep 30, 2009 | K092003 | CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE MyCardio, LLC | MNR |
| Jun 26, 2009 | K090484 | ALICE PDX Respironics Inc., Sleep & Home Respiratory Group | MNR |
| Jun 18, 2009 | K090958 | INOMAX DS (DELIVERY SYSTEM) Ino Therapeutics, LLC | MNR |
| Mar 23, 2009 | K082853 | CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR Inspired Technologies, Inc. | MNR |
| Mar 19, 2009 | K083575 | APNEALINK PLUS, MODEL: 22328 Resmed Germany, Inc. | MNR |
| Mar 6, 2009 | K083620 | SOMNOLYZER 24X7 The Siesta Group North America | MNR |
| Jan 26, 2009 | K083874 | GALAXY Respironics Inc., Sleep & Home Respiratory Group | MNR |
| Jan 2, 2009 | K082968 | APNEICARE CONNECTION CENTER/INTERNET ANALYSIS Apneicare, LLC | MNR |
| Dec 4, 2008 | K081861 | HOLTER LX ANALYSIS North East Monitoring, Inc. | MNR |
| Nov 7, 2008 | K082113 | NOX T3, NOXTURNAL (PC APPLICATION) Nox Medical, IS | MNR |
| Sep 18, 2008 | K081485 | SOMNOWATCH Somnomedics GmbH | MNR |
| Sep 2, 2008 | K080375 | RMX PHYSIOLOGICAL DATA RECORDER S.L.P. , Ltd., IL | MNR |
| Aug 14, 2008 | K081982 | WATCH-PAT 200S-2 (WP200S-2) Itamar Medical | MNR |
| Aug 8, 2008 | K073682 | EMBLETTA GOLD Embla Systems, Inc. | MNR |
| Aug 7, 2008 | K080983 | PROVENT NASAL CANNULA Ventus Medical, Inc. | MNR |
| Jul 28, 2008 | K081176 | FLOCHANNEL Chad Therapeutics, Inc. | MNR |
| Jun 9, 2008 | K081037 | WATCH-PAT 200I (WP200I) Itamar Medical | MNR |
| May 23, 2008 | K080427 | WATCH-PAT MODEL 100S-2 Itamar Medical | MNR |
| May 23, 2008 | K080321 | SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM Snap Laboratories, LLC | MNR |
| Apr 18, 2008 | K073269 | HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM Hypnocore, Ltd. | MNR |
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