Clearance Summary
PULSE RATE MONITOR received FDA 510(k) clearance under submission number K914595, sponsored by Fitness Quest, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1992-01-31.
- Submission: K914595
- Applicant / Sponsor: Fitness Quest, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2710
- Decision date: 1992-01-31
Classification & Regulation
This clearance is catalogued under FDA product code DPZ and 21 CFR 870.2710, within the Cardiovascular review panel as a Class II device.