Clearance Summary
BUBBLE TRAP-FILTER CAT. NO B180F37 received FDA 510(k) clearance under submission number K873316, sponsored by American Omni Medical, 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 1988-07-14.
- Submission: K873316
- Applicant / Sponsor: American Omni Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4260
- Decision date: 1988-07-14
Classification & Regulation
This clearance is catalogued under FDA product code DTM and 21 CFR 870.4260, within the Cardiovascular review panel as a Class II device.