Clearance Summary
PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM received FDA 510(k) clearance under submission number K871912, sponsored by Electro-Diagnostic Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-02-18.
- Submission: K871912
- Applicant / Sponsor: Electro-Diagnostic Instruments
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2120
- Decision date: 1988-02-18
Classification & Regulation
This clearance is catalogued under FDA product code DPT and 21 CFR 870.2120, within the Cardiovascular review panel as a Class II device.