The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Pro-vent(tm), Pulsator(r), And Line Draw(tm) Arterial Blood Sampling Syringes.
| Device ID | K945777 |
| 510k Number | K945777 |
| Device Name: | PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES |
| 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 | 1994-11-25 |
| Decision Date | 1994-12-22 |