Clearance Summary
OMED DISPOSABLE BULLDOG received FDA 510(k) clearance under submission number K813499, sponsored by Omega-Med Intl., 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 1981-12-29.
- Submission: K813499
- Applicant / Sponsor: Omega-Med Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 1981-12-29
Classification & Regulation
This clearance is catalogued under FDA product code DXC and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.