Clearance Summary
APNEA/BRADYCARDIA MONITOR HB 95 received FDA 510(k) clearance under submission number K830666, sponsored by Harvey-Bostwick, 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 1983-07-18.
- Submission: K830666
- Applicant / Sponsor: Harvey-Bostwick, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1983-07-18
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.