Clearance Summary
HRV 4000EM received FDA 510(k) clearance under submission number K932929, sponsored by All-Tronics Medical Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1993-09-09.
- Submission: K932929
- Applicant / Sponsor: All-Tronics Medical Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1993-09-09
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.