Clearance Summary
PHLEBOTEST 2000 received FDA 510(k) clearance under submission number K022047, sponsored by Osborn Medical 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 2002-11-04.
- Submission: K022047
- Applicant / Sponsor: Osborn Medical Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2780
- Decision date: 2002-11-04
Classification & Regulation
This clearance is catalogued under FDA product code JOM and 21 CFR 870.2780, within the Cardiovascular review panel as a Class II device.