Clearance Summary
CBG CUFF MANOMETER received FDA 510(k) clearance under submission number K873614, sponsored by Bio-Med Devices, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1988-01-22.
- Submission: K873614
- Applicant / Sponsor: Bio-Med Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5750
- Decision date: 1988-01-22
Classification & Regulation
This clearance is catalogued under FDA product code BSK and 21 CFR 868.5750, within the Anesthesiology review panel as a Class II device.