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 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260949 | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | 2026-09-24 | Traditional | PDF ↗ |
| K254042 | WatchPAT SW | Itamar Medical , Ltd. | 2026-07-31 | Traditional | PDF ↗ |
| K260050 | WRAP System | Huneo, LLC | 2026-07-15 | Traditional | PDF ↗ |
| K253148 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | 2026-06-22 | Traditional | PDF ↗ |
| K252628 | CASSIE | Wesper, Inc. | 2026-04-27 | Traditional | PDF ↗ |
| K252497 | SANSA HSAT | Huxley Medical | 2025-12-10 | Traditional | PDF ↗ |
| K250882 | SANSA HSAT | Huxley Medical | 2025-10-29 | Traditional | PDF ↗ |
| K250460 | WatchPAT400 (WP400) | Itamar Medical , Ltd. | 2025-09-05 | Traditional | PDF ↗ |
| K252383 | Somfit D | Compumedics Limited | 2025-08-28 | Special | PDF ↗ |
| K243220 | Onera STS 2 (ONERA STS 2) | Onera B.V. | 2025-07-03 | Traditional | PDF ↗ |
| K242224 | Happy Health Home Sleep Test | Happy Health, Inc. | 2025-06-18 | Traditional | PDF ↗ |
| K243092 | AcuPebble Ox (200) | Acurable Limited | 2025-03-19 | Traditional | PDF ↗ |
| K243268 | TipTraQ (TTQ001) | Pranaq Pte. , Ltd. | 2025-02-03 | Traditional | PDF ↗ |
| K244027 | SANSA HSAT | Huxley Medical | 2025-01-28 | Special | PDF ↗ |
| K242290 | DormoTech NLab | Dormotech Medical, Ltd. | 2025-01-08 | Traditional | PDF ↗ |
| K242424 | Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries, Inc. | 2024-12-18 | Traditional | PDF ↗ |
| K231667 | Withings Sleep Rx | Withings | 2024-09-06 | Traditional | PDF ↗ |
| K233501 | LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) | Largan Medical Co., Ltd. | 2024-07-26 | Traditional | PDF ↗ |
| K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | 2024-07-15 | Traditional | PDF ↗ |
| K240100 | SAM Model 9-10000 | Snap Diagnostics, LLC | 2024-06-04 | Traditional | PDF ↗ |
| K231355 | Aurora | Ensodata | 2024-02-09 | Traditional | PDF ↗ |
| K231546 | Somfit | Compumedics Limited | 2023-11-30 | Traditional | PDF ↗ |
| K223573 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2023-08-18 | Traditional | PDF ↗ |
| K221816 | Wesper Lab | Wesper, Inc. | 2023-03-09 | Traditional | PDF ↗ |
| K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | 2023-02-23 | Traditional | PDF ↗ |
| K222950 | AcuPebble OX100 | Acurable Limited | 2023-02-03 | Traditional | PDF ↗ |
| K223675 | WatchPAT ONE (WP1) | Itamar Medical , Ltd. | 2023-01-06 | Special | PDF ↗ |
| K220012 | BresoDX1 | Bresotec, Inc. | 2022-12-21 | Traditional | PDF ↗ |
| K222331 | WatchPAT300 (WP300) | Itamar Medical , Ltd. | 2022-09-14 | Special | PDF ↗ |
| K220095 | ANNE Sleep | Sibel, Inc. | 2022-07-11 | Traditional | PDF ↗ |
| K213360 | SleepCheckRx | Resapp Health | 2022-07-05 | Traditional | PDF ↗ |
| K210593 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2022-04-06 | Traditional | PDF ↗ |
| K203839 | WatchPAT200U (WP200U) | Itamar Medical , Ltd. | 2022-03-21 | Traditional | PDF ↗ |
| K220028 | NightOwl | Ectosense NV | 2022-02-24 | Special | PDF ↗ |
| K203343 | Wesper Lab | Wesper, Inc. | 2021-12-21 | Traditional | PDF ↗ |
| K213463 | NightOwl | Ectosense NV | 2021-12-16 | Special | PDF ↗ |
| K210480 | AcuPebble SA | Acurable Limited | 2021-07-06 | Traditional | PDF ↗ |
| K201495 | Maxxi Flow Sensor | Neurovirtual USA, Inc. | 2020-12-14 | Traditional | PDF ↗ |
| K200695 | MATRx plus | Zephyr Sleep Technologies | 2020-08-24 | Traditional | PDF ↗ |
| K200654 | Rubicon SA System | Dymedix Diagnostics, Inc. | 2020-07-22 | Traditional | PDF ↗ |
| K191031 | NightOwl | Ectosense NV | 2020-03-06 | Traditional | PDF ↗ |
| K191095 | Maxxi Snore Sensor | Neurovirtual USA, Inc. | 2020-01-16 | Traditional | PDF ↗ |
| K191925 | MATRx Plus | Zephyr Sleep Technologies | 2019-10-29 | Traditional | PDF ↗ |
| K183625 | SomnaPatch | Respironics, Inc. | 2019-10-18 | Traditional | PDF ↗ |
| K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant | Embla Systems | 2019-09-27 | Abbreviated | PDF ↗ |
| K182618 | SleepImage System | Mycardio, LLC Dba Sleepimage. | 2019-08-14 | Traditional | PDF ↗ |
| K173974 | DROWZLE | Resonea, Inc. | 2019-07-14 | Traditional | PDF ↗ |
| K171304 | Maxxi Rip Sensor | Neurovirtual USA, Inc. | 2019-06-24 | Traditional | PDF ↗ |
| K183559 | WatchPAT ONE | Itamar Medical , Ltd. | 2019-06-05 | Traditional | PDF ↗ |
| K173793 | XactTrace Single Use Respiratory Effort Belt System | Embla Systems | 2019-03-01 | Traditional | PDF ↗ |
| K181996 | MATRx Plus | Zephyr Sleep Technologies | 2018-11-21 | Traditional | PDF ↗ |
| K180775 | Watch-PAT300 | Itamar Medical , Ltd. | 2018-08-17 | Traditional | PDF ↗ |
| K172799 | Positional Sleep Assessment System (PoSAS) software | Advanced Brain Monitoring | 2018-03-09 | Traditional | PDF ↗ |
| K163696 | SleepImage System | Mycardio, LLC Dba Sleepimage. | 2017-10-13 | Traditional | PDF ↗ |
| K163665 | MATRx plus | Zephyr Sleep Technologies | 2017-05-05 | Traditional | PDF ↗ |
| K160499 | Apnea Risk Evaluation System (ARES), Model 620 | Watermark Medical | 2017-04-24 | Traditional | PDF ↗ |
| K161579 | Watch-PAT200U | Itamar Medical , Ltd. | 2017-02-24 | Traditional | PDF ↗ |
| K153070 | Watch-PAT200U | Itamar Medical , Ltd. | 2016-07-26 | Traditional | PDF ↗ |
| K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal | Salter Labs | 2016-04-15 | Traditional | PDF ↗ |
| K151433 | AUDICOR CA300/CC100 Analyzer with SDB | Inovise Medical, Inc. | 2016-03-18 | Traditional | PDF ↗ |
| K151361 | Nox RIP Belts & Cables | Nox Medical Ehf | 2015-11-06 | Traditional | PDF ↗ |
| K150102 | SnoreSounds | Appian Medical, Inc. | 2015-11-05 | Traditional | PDF ↗ |
| K143272 | ApneaLink Air | Resmed Germany, Inc. | 2015-04-30 | Traditional | PDF ↗ |
| K140861 | SOMNOTOUCH RESP | Somnomedics GmbH | 2015-01-30 | Traditional | PDF ↗ |
| K133859 | WATCH-PAT200U (WP200U) | Itamar Medical , Ltd. | 2014-05-30 | Traditional | PDF ↗ |
| K131883 | AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) | Inovise Medical, Inc. | 2014-04-11 | Traditional | PDF ↗ |
| K131932 | APNEALINK PRO | Resmed Germany, Inc. | 2013-11-08 | Traditional | PDF ↗ |
| K131994 | SOMNOLYZER 24X7 | Respironics, Inc. | 2013-10-17 | Traditional | PDF ↗ |
| K124062 | QDC-PRO, AND NOX-RIP | Nox Medical | 2013-07-10 | Traditional | PDF ↗ |
| K122516 | EMBLETTA MPR | Embla Systems | 2013-02-21 | Traditional | PDF ↗ |
| K112514 | APNEA RISK EVALUATION SYSTEM (ARES) | Advanced Brain Monitoring, Inc. | 2012-01-09 | Traditional | PDF ↗ |
| K112822 | SLEEPSTRIP II | S.L.P. , Ltd. | 2011-12-27 | Traditional | PDF ↗ |
| K112102 | MICHELE SLEEP SCORING SYSTEMS | Younes Sleep Technologies | 2011-12-20 | Traditional | PDF ↗ |
| K111742 | MDRIVE | Embla Systems | 2011-08-31 | Special | PDF ↗ |
| K111314 | MORPHEUS OX | Widemed, Ltd. | 2011-08-31 | Traditional | PDF ↗ |
| K110486 | ACCUSOM | Novasom, Inc. | 2011-08-12 | Traditional | PDF ↗ |
| K111194 | APNEA RISK EVALUATION SYSTEM (ARES) | Advanced Brain Monitoring, Inc. | 2011-07-07 | Special | PDF ↗ |
| K102567 | WATCH-PAT 200S-3 (WP200S-3) | Itamar Medical , Ltd. | 2011-06-02 | Traditional | PDF ↗ |
| K110705 | APNEA RISK EVALUATION SYSTEM (ARES) | Advanced Brain Monitoring, Inc. | 2011-04-14 | Special | PDF ↗ |
| K110064 | SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM | Snap Diagnostics, LLC | 2011-03-18 | Special | PDF ↗ |
| K092003 | CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE | MyCardio, LLC | 2009-09-30 | Traditional | PDF ↗ |
| K090484 | ALICE PDX | Respironics Inc., Sleep & Home Respiratory Group | 2009-06-26 | Traditional | PDF ↗ |
| K090958 | INOMAX DS (DELIVERY SYSTEM) | Ino Therapeutics, LLC | 2009-06-18 | Special | PDF ↗ |
| K082853 | CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR | Inspired Technologies, Inc. | 2009-03-23 | Traditional | PDF ↗ |
| K083575 | APNEALINK PLUS, MODEL: 22328 | Resmed Germany, Inc. | 2009-03-19 | Traditional | PDF ↗ |
| K083620 | SOMNOLYZER 24X7 | The Siesta Group North America | 2009-03-06 | Traditional | PDF ↗ |
| K083874 | GALAXY | Respironics Inc., Sleep & Home Respiratory Group | 2009-01-26 | Traditional | PDF ↗ |
| K082968 | APNEICARE CONNECTION CENTER/INTERNET ANALYSIS | Apneicare, LLC | 2009-01-02 | Traditional | PDF ↗ |
| K081861 | HOLTER LX ANALYSIS | North East Monitoring, Inc. | 2008-12-04 | Traditional | PDF ↗ |
| K082113 | NOX T3, NOXTURNAL (PC APPLICATION) | Nox Medical | 2008-11-07 | Traditional | PDF ↗ |
| K081485 | SOMNOWATCH | Somnomedics GmbH | 2008-09-18 | Traditional | PDF ↗ |
| K080375 | RMX PHYSIOLOGICAL DATA RECORDER | S.L.P. , Ltd. | 2008-09-02 | Traditional | PDF ↗ |
| K081982 | WATCH-PAT 200S-2 (WP200S-2) | Itamar Medical | 2008-08-14 | Special | PDF ↗ |
| K073682 | EMBLETTA GOLD | Embla Systems, Inc. | 2008-08-08 | Traditional | PDF ↗ |
| K080983 | PROVENT NASAL CANNULA | Ventus Medical, Inc. | 2008-08-07 | Traditional | PDF ↗ |
| K081176 | FLOCHANNEL | Chad Therapeutics, Inc. | 2008-07-28 | Traditional | PDF ↗ |
| K081037 | WATCH-PAT 200I (WP200I) | Itamar Medical | 2008-06-09 | Special | PDF ↗ |
| K080427 | WATCH-PAT MODEL 100S-2 | Itamar Medical | 2008-05-23 | Traditional | PDF ↗ |
| K080321 | SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM | Snap Laboratories, LLC | 2008-05-23 | Special | PDF ↗ |
| K073269 | HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM | Hypnocore, Ltd. | 2008-04-18 | Traditional | PDF ↗ |
Product code MNR · Class II · Anesthesiology. Data: openFDA.