The following data is part of a premarket notification filed by Sendx Medical, Inc. with the FDA for Sendx 100 Ph, Blood Gas And Electrolyte Analysis System.
| Device ID | K973742 |
| 510k Number | K973742 |
| Device Name: | SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY Carlsbad, CA 92011 |
| Contact | Ruben Chairez |
| Correspondent | Ruben Chairez SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY Carlsbad, CA 92011 |
| Product Code | CGZ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | GKF |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-01 |
| Decision Date | 1997-12-03 |
| Summary: | summary |