Clearance Summary
HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 received FDA 510(k) clearance under submission number K821942, 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 1982-08-24.
- Submission: K821942
- Applicant / Sponsor: Harvey-Bostwick, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1982-08-24
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.