Clearance Summary
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE received FDA 510(k) clearance under submission number K001852, sponsored by Itamar Medical (C.M.) 1997 , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-02-21.
- Submission: K001852
- Applicant / Sponsor: Itamar Medical (C.M.) 1997 , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2001-02-21
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.