Clearance Summary
DVT PREVENTION SYS. MBE 22 PRESSURE U. received FDA 510(k) clearance under submission number K800337, sponsored by Med-Bio Engineering, 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 1980-03-25.
- Submission: K800337
- Applicant / Sponsor: Med-Bio Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 1980-03-25
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.