WatchPAT ONE E
WatchPAT ONE E (AC2110850) is a polysomnograph (FDA Class II; FDA product code MNR, Ventilatory Effort Recorder) made by Itamar Medical Ltd, cleared under FDA 510(k) K223675 on 6 Jan 2023 (1 earlier submission) and listed in FDA GUDID since 12 May 2020 (UDI-DI 07290109222547), active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223675 | Date6 Jan 2023 | StatusActive |
| United States | GUDID listing | Number07290109222547 | Date12 May 2020 | StatusListed |
Official records
- AccessGUDID record 07290109222547
- FDA 510(k) database K223675
- FDA 510(k) database K183559
Across registries
- FDA 510(k) K223675 decided 6 Jan 2023 Active
- FDA GUDID UDI-DI 07290109222547 listed 12 May 2020 Listed
Timeline
- Cleared FDA 510(k) K183559
- Listed FDA GUDID 07290109222547
- Cleared FDA 510(k) K223675
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- WatchPAT ONE
- Generic name
- Polysomnograph
- Model / Ref / Catalog
- WatchPAT ONE E, AC2110850
- Primary DI / UDI-DI
- 07290109222547
- FDA product code
- MNR
- GMDN term
- Polysomnograph
- Device class
- Class II
- Regulation number
- 868.2375
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Polysomnograph.