The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Aspir-pulse(tm) Saf-t-vent.
| Device ID | K940575 |
| 510k Number | K940575 |
| Device Name: | ASPIR-PULSE(TM) SAF-T-VENT |
| Classification | Arterial Blood Sampling Kit |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-07 |
| Decision Date | 1994-03-22 |