The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Sims Pro-vent 250 (500) Plus Arterial Blood Sampling Kit.
| Device ID | K962931 |
| 510k Number | K962931 |
| Device Name: | SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-29 |
| Decision Date | 1996-10-21 |
| Summary: | summary |