FDA 510(k) Applications for Medical Device Product Code "MNR"
(Ventilatory Effort Recorder)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K222950 | Acurable Limited | AcuPebble OX100 | 02/03/2023 |
| K210480 | Acurable Limited | AcuPebble SA | 07/06/2021 |
| K172799 | Advanced Brain Monitoring | Positional Sleep Assessment System (PoSAS) software | 03/09/2018 |
| K110705 | ADVANCED BRAIN MONITORING INC. | APNEA RISK EVALUATION SYSTEM (ARES) | 04/14/2011 |
| K111194 | ADVANCED BRAIN MONITORING, INC. | APNEA RISK EVALUATION SYSTEM (ARES) | 07/07/2011 |
| K112514 | ADVANCED BRAIN MONITORING, INC. | APNEA RISK EVALUATION SYSTEM (ARES) | 01/09/2012 |
| K041662 | ADVANCED BRAIN MONITORING, INC. | APNEA RISK EVALUATION SYSTEM (ARES) | 10/14/2004 |
| K071230 | ADVANCED BRAIN MONITORING, INC. | APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 | 10/03/2007 |
| K990321 | ALPHAMED, INC. | ALPHAMED GEMINI SENSOR, SNORING SENSOR | 06/01/1999 |
| K082968 | APNEICARE, LLC | APNEICARE CONNECTION CENTER/INTERNET ANALYSIS | 01/02/2009 |
| K150102 | APPIAN MEDICAL, INC. | SnoreSounds | 11/05/2015 |
| K222579 | Belun Technology Company Limited | Belun Sleep System BLS-100 | 02/23/2023 |
| K962103 | BIO-LOGIC SYSTEMS CORP. | BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER | 08/22/1996 |
| K971501 | BIO-LOGIC SYSTEMS CORP. | SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER | 10/14/1997 |
| K020607 | BIOMEC, INC. | SLEEPFLO, MODEL 101501 | 08/30/2002 |
| K061764 | BRAEBON MEDICAL CORP. | MEDIBYTE, MODEL MP8 | 09/06/2006 |
| K020312 | BRAEBON MEDICAL CORP. | ULTIMA SNORING MIKE, MODEL 0540 | 08/07/2002 |
| K220012 | Bresotec Inc | BresoDX1 | 12/21/2022 |
| K061705 | CADWELL LABORATORIES, INC. | CADWELL EASYNET NASAL PRESSURE MODULE | 11/21/2006 |
| K081176 | CHAD THERAPEUTICS, INC. | FLOCHANNEL | 07/28/2008 |
| K072201 | COMPUMEDICS LIMITED | COMPUMEDICS SOMTE PSG RECORDING SYSTEM | 04/14/2008 |
| K021176 | COMPUMEDICS LIMITED | COMPUMEDICS SOMTE SYSTEM | 01/21/2003 |
| K955841 | COMPUMEDICS PTD LTD. | SLEEP SYSTEM FOR CLINICS & RESEARCH | 03/11/1997 |
| K040194 | COMPUMEDICS USA, LTD. | COMPUMEDICS SUMMIT IP | 04/23/2004 |
| K042745 | DEL MAR REYNOLDS MEDICAL, INC. | LIFESCREEN APNEA | 01/19/2005 |
| K200654 | Dymedix Diagnostics, Inc. | Rubicon SA System | 07/22/2020 |
| K040069 | DYMEDIX, INC. | DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR | 05/05/2004 |
| K070855 | DYNADX CORPORATION | SLEEP QUALITY | 03/20/2008 |
| K061996 | EB NEURO, S.P.A. | SANDMAN POCKET | 10/03/2006 |
| K213463 | Ectosense nv | NightOwl | 12/16/2021 |
| K191031 | Ectosense nv | NightOwl | 03/06/2020 |
| K220028 | Ectosense nv | NightOwl | 02/24/2022 |
| K180001 | Embla Systems | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant | 09/27/2019 |
| K122516 | EMBLA SYSTEMS | EMBLETTA MPR | 02/21/2013 |
| K111742 | EMBLA SYSTEMS | MDRIVE | 08/31/2011 |
| K173793 | Embla Systems | XactTrace Single Use Respiratory Effort Belt System | 03/01/2019 |
| K073682 | EMBLA SYSTEMS, INC. | EMBLETTA GOLD | 08/08/2008 |
| K021138 | ERICH JAEGER GMBH | SLEEPSCREEN/APNOESCREEN CARDIO | 02/12/2003 |
| K000396 | ERICH JAEGER, INC. | APNOESCREEN PRO, ALPHA SCREEN PRO | 12/27/2000 |
| K983572 | HEALTHDYNE TECHNOLOGIES, INC. | SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 | 03/19/1999 |
| K073269 | HYPNOCORE, LTD. | HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM | 04/18/2008 |
| K022294 | IM SYSTEMS | APNEACHECK | 04/25/2003 |
| K002135 | INFLUENT LTD. | SLEEPSTRIP DISPOSABLE APNEA SCREENER | 12/06/2000 |
| K090958 | INO THERAPEUTICS LLC | INOMAX DS (DELIVERY SYSTEM) | 06/18/2009 |
| K151433 | INOVISE MEDICAL, INC. | AUDICOR CA300/CC100 Analyzer with SDB | 03/18/2016 |
| K131883 | INOVISE MEDICAL, INC. | AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) | 04/11/2014 |
| K082853 | INSPIRED TECHNOLOGIES, INC. | CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR | 03/23/2009 |
| K042916 | ITAMAR MEDICAL | WATCH PAT 100S | 12/29/2004 |
| K081037 | ITAMAR MEDICAL | WATCH-PAT 200I (WP200I) | 06/09/2008 |
| K081982 | ITAMAR MEDICAL | WATCH-PAT 200S-2 (WP200S-2) | 08/14/2008 |
| K080427 | ITAMAR MEDICAL | WATCH-PAT MODEL 100S-2 | 05/23/2008 |
| K010156 | ITAMAR MEDICAL (C.M.) 1997 LTD. | SLEEP PAT 200 DEVICE | 06/19/2002 |
| K010739 | ITAMAR MEDICAL (C.M.) 1997 LTD. | WATCH-PAT 100 | 11/06/2001 |
| K102567 | ITAMAR MEDICAL LTD | WATCH-PAT 200S-3 (WP200S-3) | 06/02/2011 |
| K133859 | ITAMAR MEDICAL LTD | WATCH-PAT200U (WP200U) | 05/30/2014 |
| K223675 | Itamar Medical, LTD | WatchPAT ONE (WP1) | 01/06/2023 |
| K222331 | Itamar Medical, Ltd | WatchPAT300 (WP300) | 09/14/2022 |
| K153070 | ITAMAR MEDICAL, LTD. | Watch-PAT200U | 07/26/2016 |
| K161579 | ITAMAR MEDICAL, LTD. | Watch-PAT200U | 02/24/2017 |
| K180775 | Itamar Medical, Ltd. | Watch-PAT300 | 08/17/2018 |
| K183559 | Itamar Medical, Ltd. | WatchPAT ONE | 06/05/2019 |
| K203839 | Itamar Medical, Ltd. | WatchPAT200U (WP200U) | 03/21/2022 |
| K963597 | LOCAL SILENCE, INC. | SILENT NIGHT I | 01/23/1997 |
| K040576 | MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH | MICROMESAM BASIC-SET | 07/01/2004 |
| K041904 | MEDCARE FLAGA | COMPASS F10 SYSTEM | 09/07/2004 |
| K041724 | MEDCARE FLAGA | COMPASS M10 SYSTEM | 09/28/2004 |
| K024322 | MEDCARE FLAGA | EMBLA N7000 | 10/27/2003 |
| K043132 | MEDCARE FLAGA | UNIVERSAL XACTTRACE | 12/21/2004 |
| K092003 | MyCardio, LLC | CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE | 09/30/2009 |
| K182618 | MyCardio, LLC dba SleepImage. | SleepImage System | 08/14/2019 |
| K163696 | MyCardio, LLC dba SleepImage. | SleepImage System | 10/13/2017 |
| K030611 | NELLCOR PURITAN BENNETT (MELVILLE) LTD. | MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM | 03/24/2003 |
| K964494 | NELLCOR PURITAN BENNETT, INC. | SLEEPWIZARD | 02/04/1997 |
| K990565 | NELLCOR PURITAN BENNETT, INC. | SUZANNE | 08/18/1999 |
| K971803 | NEUROTRONICS, INC. | NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 | 11/12/1997 |
| K201495 | Neurovirtual USA, INC. | Maxxi Flow Sensor | 12/14/2020 |
| K171304 | Neurovirtual USA, INC. | Maxxi Rip Sensor | 06/24/2019 |
| K191095 | Neurovirtual USA, INC. | Maxxi Snore Sensor | 01/16/2020 |
| K081861 | NORTH EAST MONITORING INC. | HOLTER LX ANALYSIS | 12/04/2008 |
| K110486 | NOVASOM, INC. | ACCUSOM | 08/12/2011 |
| K082113 | NOX MEDICAL | NOX T3, NOXTURNAL (PC APPLICATION) | 11/07/2008 |
| K124062 | NOX MEDICAL | QDC-PRO, AND NOX-RIP | 07/10/2013 |
| K151361 | NOX MEDICAL ehf | Nox RIP Belts & Cables | 11/06/2015 |
| K210593 | Onera B.V. | Onera Sleep Test System (Onera STS) | 04/06/2022 |
| K223573 | Onera B.V. | Onera Sleep Test System (Onera STS) | 08/18/2023 |
| K013905 | PRO-TECH SERVICES, INC. | MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS | 04/22/2002 |
| K033402 | PRO-TECH SERVICES, INC. | PORTABLE SLEEP DATA RECORDER (PSDR) | 06/30/2004 |
| K982293 | PRO-TECH SERVICES, INC. | PRESSURE TRANSDUCER AIRFLOW SENSOR | 07/13/1998 |
| K213360 | ResApp Health | SleepCheckRx | 07/05/2022 |
| K070263 | RESMED GERMANY INC. | APNEALINK | 06/15/2007 |
| K143272 | RESMED GERMANY INC. | ApneaLink Air | 04/30/2015 |
| K083575 | RESMED GERMANY INC. | APNEALINK PLUS, MODEL: 22328 | 03/19/2009 |
| K131932 | RESMED GERMANY INC. | APNEALINK PRO | 11/08/2013 |
| K061405 | RESMED GERMANY INC. | APNEALINK, MODEL 22302 | 07/25/2006 |
| K173974 | Resonea, Inc. | DROWZLE | 07/14/2019 |
| K090484 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | ALICE PDX | 06/26/2009 |
| K083874 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | GALAXY | 01/26/2009 |
| K990199 | RESPIRONICS, INC. | SMARTRECORDER, MODEL 2500 | 04/19/1999 |
| K183625 | Respironics, Inc. | SomnaPatch | 10/18/2019 |
| K131994 | RESPIRONICS, INC. | SOMNOLYZER 24X7 | 10/17/2013 |
| K973920 | RESPIRONICS, INC. | STARDUST | 05/14/1998 |
| K052573 | RESPIRONICS, INC. | STARDUST II | 12/13/2005 |
| K021845 | RESPIRONICS, INC. | STARDUST II, MODEL 1011176 | 05/20/2004 |
| K112822 | S.L.P LTD. | SLEEPSTRIP II | 12/27/2011 |
| K080375 | S.L.P. LTD. | RMX PHYSIOLOGICAL DATA RECORDER | 09/02/2008 |
| K042253 | S.L.P. LTD. | SLEEPSENSE SLEEP SENSORS | 10/06/2004 |
| K002159 | SAGATECH ELECTRONICS, INC. | SNORE SAT RECORDER, MODEL SS41 | 06/28/2002 |
| K051313 | SALTER LABS | BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER | 09/15/2005 |
| K151874 | Salter Labs | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal | 04/15/2016 |
| K030379 | SECTOR MEDICAL CORP. | APLAB, MODEL 801D0030 | 08/29/2003 |
| K220095 | Sibel Inc. | ANNE Sleep | 07/11/2022 |
| K981034 | SLEEP SOLUTIONS, INC. | SILENT NIGHT II | 10/30/1998 |
| K000253 | SLEEP SOLUTIONS, INC. | SILENT NIGHT V | 11/16/2000 |
| K110064 | SNAP DIAGNOSTICS, L.L.C. | SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM | 03/18/2011 |
| K984169 | SNAP LABORATORIES, L.L.C. | DIGI-SNAP | 05/26/1999 |
| K971184 | SNAP LABORATORIES, L.L.C. | OXI-SNAP | 10/01/1997 |
| K992322 | SNAP LABORATORIES, L.L.C. | SNAP MODEL 5 | 02/02/2000 |
| K002095 | SNAP LABORATORIES, L.L.C. | SNAP MODEL 6 | 03/02/2001 |
| K080321 | SNAP LABORATORIES, L.L.C. | SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM | 05/23/2008 |
| K071556 | SOMNOMEDICS GMBH | SOMNOSCREEN EEG10-20 | 07/18/2007 |
| K140861 | SOMNOMEDICS GMBH | SOMNOTOUCH RESP | 01/30/2015 |
| K081485 | SOMNOMEDICS GMBH | SOMNOWATCH | 09/18/2008 |
| K060708 | SOMNOMEDICS GMBH & CO. KG | SOMNOSCREEN | 01/24/2007 |
| K012437 | SUNRISE MEDICAL HHG, INC. | DEVILBISS SLEEP RECORDER MODEL # RM60 | 07/16/2002 |
| K083620 | THE SIESTA GROUP NORTH AMERICA | SOMNOLYZER 24X7 | 03/06/2009 |
| K080983 | VENTUS MEDICAL, INC. | PROVENT NASAL CANNULA | 08/07/2008 |
| K072014 | VITASCORE B.V. | VITASCORE | 11/08/2007 |
| K160499 | Watermark Medical | Apnea Risk Evaluation System (ARES), Model 620 | 04/24/2017 |
| K221816 | Wesper Inc. | Wesper Lab | 03/09/2023 |
| K203343 | Wesper Inc. | Wesper Lab | 12/21/2021 |
| K022506 | WIDEMED LTD | MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM | 05/15/2003 |
| K111314 | WIDEMED LTD | MORPHEUS OX | 08/31/2011 |
| K070326 | WIDEMED LTD | NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM | 05/05/2007 |
| K112102 | YOUNES SLEEP TECHNOLOGIES | MICHELE SLEEP SCORING SYSTEMS | 12/20/2011 |
| K181996 | Zephyr Sleep Technologies | MATRx Plus | 11/21/2018 |
| K191925 | Zephyr Sleep Technologies | MATRx Plus | 10/29/2019 |
| K200695 | Zephyr Sleep Technologies | MATRx plus | 08/24/2020 |
| K163665 | Zephyr Sleep Technologies | MATRx plus | 05/05/2017 |
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