Clearance Summary
VASCULAB BI-DIRECTIONAL DOPPLER, #D10 received FDA 510(k) clearance under submission number K800768, sponsored by Medasonics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1980-07-08.
- Submission: K800768
- Applicant / Sponsor: Medasonics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1540
- Decision date: 1980-07-08
Classification & Regulation
This clearance is catalogued under FDA product code JAF and 21 CFR 892.1540, within the Radiology review panel as a Class II device.