The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Sherwood Medical Arterial Blood Gas Kit I.
Device ID | K925453 |
510k Number | K925453 |
Device Name: | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I |
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 - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-28 |
Decision Date | 1993-07-12 |