The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Serum Bicarbonate/carbon Dioxide.
Device ID | K955302 |
510k Number | K955302 |
Device Name: | SERUM BICARBONATE/CARBON DIOXIDE |
Classification | Enzymatic, Carbon-dioxide |
Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Contact | C.h. Morris |
Correspondent | C.h. Morris DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Product Code | KHS |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-20 |
Decision Date | 1996-02-29 |