Clearance Summary
50MM WRITER MODEL CVM 9529 received FDA 510(k) clearance under submission number K792099, 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 1979-10-26.
- Submission: K792099
- Applicant / Sponsor: C-V Monitors Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2810
- Decision date: 1979-10-26
Classification & Regulation
This clearance is catalogued under FDA product code DSF and 21 CFR 870.2810, within the Cardiovascular review panel as a Class I device.