The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Artap Arterial Blood Sampling Device.
Device ID | K843360 |
510k Number | K843360 |
Device Name: | ARTAP ARTERIAL BLOOD SAMPLING DEVICE |
Classification | Arterial Blood Sampling Kit |
Applicant | ANALYTICAL PRODUCTS, INC. 511 TAYLOR WAY Belmont , CA 94002 - |
Contact | Berry Dodd |
Correspondent | Berry Dodd ANALYTICAL PRODUCTS, INC. 511 TAYLOR WAY Belmont , CA 94002 - |
Product Code | CBT |
CFR Regulation Number | 868.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-28 |
Decision Date | 1984-10-31 |