Clearance Summary
SCANHEADS-ACCESS 10PV, BIOSTATIC received FDA 510(k) clearance under submission number K843620, sponsored by Advanced Technology Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-03-12.
- Submission: K843620
- Applicant / Sponsor: Advanced Technology Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2880
- Decision date: 1985-03-12
Classification & Regulation
This clearance is catalogued under FDA product code JOP and 21 CFR 870.2880, within the Cardiovascular review panel as a Class II device.