Clearance Summary
HOLTA-MED RECORDER received FDA 510(k) clearance under submission number K832395, sponsored by Holta-Med. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1983-10-20.
- Submission: K832395
- Applicant / Sponsor: Holta-Med
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1983-10-20
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.