Clearance Summary
BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST received FDA 510(k) clearance under submission number K921048, sponsored by Colin Medical Instruments 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 1993-07-01.
- Submission: K921048
- Applicant / Sponsor: Colin Medical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1993-07-01
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.