Clearance Summary
Watch-PAT300 received FDA 510(k) clearance under submission number K180775, sponsored by Itamar Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2018-08-17.
- Submission: K180775
- Applicant / Sponsor: Itamar Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 2018-08-17
Classification & Regulation
This clearance is catalogued under FDA product code MNR and 21 CFR 868.2375, within the Anesthesiology review panel as a Class II device.