Clearance Summary
BIOCUFF INFUSION BAG PRESSOR received FDA 510(k) clearance under submission number K832377, sponsored by Bio-Medical Instruments , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1983-08-12.
- Submission: K832377
- Applicant / Sponsor: Bio-Medical Instruments , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5420
- Decision date: 1983-08-12
Classification & Regulation
This clearance is catalogued under FDA product code KZD and 21 CFR 880.5420, within the General Hospital review panel as a Class I device.