The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Arterial Blood Sampling Kit.
Device ID | K902771 |
510k Number | K902771 |
Device Name: | ARTERIAL BLOOD SAMPLING KIT |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
Contact | Cathy Chenetski |
Correspondent | Cathy Chenetski MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-21 |
Decision Date | 1990-11-05 |