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 |