Clearance Summary
SLEEP PAT 200 DEVICE received FDA 510(k) clearance under submission number K010156, sponsored by Itamar Medical (C.M.) 1997 , 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 2002-06-19.
- Submission: K010156
- Applicant / Sponsor: Itamar Medical (C.M.) 1997 , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 2002-06-19
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.