Clearance Summary
COLIN PRESS MATE, MODEL BP S510 received FDA 510(k) clearance under submission number K063690, sponsored by Omron Healthcare, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-05-09.
- Submission: K063690
- Applicant / Sponsor: Omron Healthcare, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2007-05-09
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.