Product code MNR
- Device name
- Ventilatory Effort Recorder
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.2375
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252628 | CASSIE | Wesper, Inc. | 2026-04-27 |
| K252497 | SANSA HSAT | Huxley Medical | 2025-12-10 |
| K250882 | SANSA HSAT | Huxley Medical | 2025-10-29 |
| K250460 | WatchPAT400 (WP400) | Itamar Medical , Ltd. | 2025-09-05 |
| K252383 | Somfit D | Compumedics Limited | 2025-08-28 |
| K243220 | Onera STS 2 (ONERA STS 2) | Onera B.V. | 2025-07-03 |
| K242224 | Happy Health Home Sleep Test | Happy Health, Inc. | 2025-06-18 |
| K243092 | AcuPebble Ox (200) | Acurable Limited | 2025-03-19 |
| K243268 | TipTraQ (TTQ001) | Pranaq Pte. , Ltd. | 2025-02-03 |
| K244027 | SANSA HSAT | Huxley Medical | 2025-01-28 |
| K242290 | DormoTech NLab | Dormotech Medical, Ltd. | 2025-01-08 |
| K242424 | Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries, Inc. | 2024-12-18 |
| K231667 | Withings Sleep Rx | Withings | 2024-09-06 |
| K233501 | “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) | Largan Medical Co., Ltd. | 2024-07-26 |
| K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | 2024-07-15 |
| K240100 | SAM Model 9-10000 | Snap Diagnostics, LLC | 2024-06-04 |
| K231355 | Aurora | Ensodata | 2024-02-09 |
| K231546 | Somfit | Compumedics Limited | 2023-11-30 |
| K223573 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2023-08-18 |
| K221816 | Wesper Lab | Wesper, Inc. | 2023-03-09 |
| K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | 2023-02-23 |
| K222950 | AcuPebble OX100 | Acurable Limited | 2023-02-03 |
| K223675 | WatchPAT ONE (WP1) | Itamar Medical , Ltd. | 2023-01-06 |
| K220012 | BresoDX1 | Bresotec, Inc. | 2022-12-21 |
| K222331 | WatchPAT300 (WP300) | Itamar Medical , Ltd. | 2022-09-14 |
| K220095 | ANNE Sleep | Sibel, Inc. | 2022-07-11 |
| K213360 | SleepCheckRx | Resapp Health | 2022-07-05 |
| K210593 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2022-04-06 |
| K203839 | WatchPAT200U (WP200U) | Itamar Medical , Ltd. | 2022-03-21 |
| K220028 | NightOwl | Ectosense NV | 2022-02-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08885021950136 | TipTraQ | PRANAQ PTE. LTD. | 2026-05-18 |
| 08885021950013 | TipTraQ | PRANAQ PTE. LTD. | 2026-05-18 |
| 08720256698371 | Onera STS 2 | Onera B.V. | 2026-05-15 |
| 08885021950044 | TipTraQ | PRANAQ PTE. LTD. | 2026-05-15 |
| 08720256698531 | Onera STS | Onera B.V. | 2026-05-15 |
| 08720256698524 | Onera STS | Onera B.V. | 2026-05-15 |
| 08720256698517 | Onera STS | Onera B.V. | 2026-05-15 |
| 08720256698500 | Onera STS | Onera B.V. | 2026-05-15 |
| 08720256698494 | Onera STS | Onera B.V. | 2026-05-15 |
| 08720256698487 | Onera STS | Onera B.V. | 2026-05-15 |
| 08720256698463 | Onera STS | Onera B.V. | 2026-05-15 |
| 08720256698364 | Onera STS 2 | Onera B.V. | 2026-05-15 |
| 08720256698357 | Onera STS 2 | Onera B.V. | 2026-05-15 |
| 08720256698340 | Onera STS 2 | Onera B.V. | 2026-05-15 |
| 08720256698333 | Onera STS 2 | Onera B.V. | 2026-05-15 |
| 08720256698326 | Onera STS 2 | Onera B.V. | 2026-05-15 |
| 08720256698319 | Onera STS 2 | Onera B.V. | 2026-05-15 |
| 08720256698302 | Onera STS 2 | Onera B.V. | 2026-05-15 |
| 08720256698296 | Onera STS 2 | Onera B.V. | 2026-05-15 |
| 08885021950051 | TipTraQ | PRANAQ PTE. LTD. | 2026-05-11 |
| 09342451002785 | Compumedics Falcon | COMPUMEDICS LIMITED | 2026-03-12 |
| 10850015266192 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2024-03-14 |
| 08056446900017 | BE Micro Recorder | EB NEURO SPA | 2019-04-02 |
| 08056446900949 | BE Micro 21 CH MONO PLUG-IN HEADBOX | EB NEURO SPA | 2019-04-02 |
| 08056446900000 | BE Micro | EB NEURO SPA | 2019-04-01 |
| 10851113007939 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2019-01-10 |
| 10851113007038 | Night Shift | ADVANCED BRAIN MONITORING, INC. | 2016-09-23 |
| 15694311110644 | Nox RIP Starter Kit E, S/M/L | Nox Medical ehf. | 2016-09-16 |
| 15694311110651 | Nox RIP Starter Kit E, M | Nox Medical ehf. | 2016-09-16 |
| 15694311110668 | Nox RIP Belts and Cannula Kit S/M/L | Nox Medical ehf. | 2016-09-16 |