Clearance Summary
DCG PREAMPLIFIER MODULE received FDA 510(k) clearance under submission number K780572, sponsored by C-V Monitors Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1978-05-09.
- Submission: K780572
- Applicant / Sponsor: C-V Monitors Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2050
- Decision date: 1978-05-09
Classification & Regulation
This clearance is catalogued under FDA product code DRR and 21 CFR 870.2050, within the Cardiovascular review panel as a Class II device.