Clearance Summary
MONITOR SCOPES, MODELS 9502, 9503 received FDA 510(k) clearance under submission number K790004, 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 1979-02-28.
- Submission: K790004
- Applicant / Sponsor: C-V Monitors Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1979-02-28
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.