Clearance Summary
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT received FDA 510(k) clearance under submission number K962931, sponsored by Smiths Industries Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1996-10-21.
- Submission: K962931
- Applicant / Sponsor: Smiths Industries Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 1996-10-21
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.