Clearance Summary
DISPOSABLE, STERILE TRANSDUCER DOMES received FDA 510(k) clearance under submission number K810735, sponsored by Bio-Med 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 1981-05-08.
- Submission: K810735
- Applicant / Sponsor: Bio-Med Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2850
- Decision date: 1981-05-08
Classification & Regulation
This clearance is catalogued under FDA product code DRS and 21 CFR 870.2850, within the Cardiovascular review panel as a Class II device.