510(k) K222331
K222331 is an FDA 510(k) premarket notification submitted by Itamar Medical , Ltd. for the device "WatchPAT300 (WP300)". The FDA issued a decision of Substantially Equivalent on September 14, 2022. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Itamar Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2022
- Date Received
- August 2, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type