Clearance Summary
A-V IMPULSE SYSTEM MODEL 6060 received FDA 510(k) clearance under submission number K964425, sponsored by Powell,Goldstein,Frazer & Murphy. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-07-28.
- Submission: K964425
- Applicant / Sponsor: Powell,Goldstein,Frazer & Murphy
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 1997-07-28
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.