MNR — Ventilatory Effort Recorder Class II
FDA product code MNR covers "Ventilatory Effort Recorder", a Class II medical device regulated under 21 CFR 868.2375. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MNR
- Device Class
- Class II
- Regulation Number
- 868.2375
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260050 | huneo | WRAP System | July 15, 2026 |
| K253148 | vivaquant, inc. dba rhythm express | RX-1 Sleep | June 22, 2026 |
| K252628 | wesper | CASSIE | April 27, 2026 |
| K252497 | huxley medical | SANSA HSAT | December 10, 2025 |
| K250882 | huxley medical | SANSA HSAT | October 29, 2025 |
| K250460 | itamar medical | WatchPAT400 (WP400) | September 5, 2025 |
| K252383 | compumedics limited | Somfit D | August 28, 2025 |
| K243220 | onera | Onera STS 2 (ONERA STS 2) | July 3, 2025 |
| K242224 | happy health | Happy Health Home Sleep Test | June 18, 2025 |
| K243092 | acurable limited | AcuPebble Ox (200) | March 19, 2025 |
| K243268 | pranaq pte. | TipTraQ (TTQ001) | February 3, 2025 |
| K244027 | huxley medical | SANSA HSAT | January 28, 2025 |
| K242290 | dormotech medical | DormoTech NLab | January 8, 2025 |
| K242424 | cadwell industries | Bluebird Single-Use Respiratory Effort Belt | December 18, 2024 |
| K231667 | withings | Withings Sleep Rx | September 6, 2024 |
| K233501 | largan medical co | LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP | July 26, 2024 |
| K240285 | huxley medical | Huxley SANSA Home Sleep Apnea Test (1000-00) | July 15, 2024 |
| K240100 | snap diagnostics | SAM Model 9-10000 | June 4, 2024 |
| K231355 | ensodata | Aurora | February 9, 2024 |
| K231546 | compumedics limited | Somfit | November 30, 2023 |