The following data is part of a premarket notification filed by Sendx Medical, Inc. with the FDA for Abl 77 Ph, Blood Gas And Electrolyte Analysis System.
| Device ID | K994346 |
| 510k Number | K994346 |
| Device Name: | ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY Carlsbad, CA 92011 |
| Contact | Martin Sellers |
| Correspondent | Martin Sellers SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY Carlsbad, CA 92011 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-02-01 |