The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Aspir-pulse(tm) Arterial Blood Gas (abg) System.
| Device ID | K945719 |
| 510k Number | K945719 |
| Device Name: | ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM |
| Classification | Arterial Blood Sampling Kit |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | K M Kroehnke |
| Correspondent | K M Kroehnke SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-21 |
| Decision Date | 1995-03-16 |