The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Data Zyme Co2 Procedure.
| Device ID | K850903 |
| 510k Number | K850903 |
| Device Name: | DATA ZYME CO2 PROCEDURE |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Contact | Jerry A Graham |
| Correspondent | Jerry A Graham 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 | 1985-03-05 |
| Decision Date | 1985-04-08 |