The following data is part of a premarket notification filed by Sendx Medical, Inc. with the FDA for Abl 80 Co-ox System.
| Device ID | K080370 |
| 510k Number | K080370 |
| Device Name: | ABL 80 CO-OX SYSTEM |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY Carlsbad, CA 92011 |
| Contact | Mark A Dzendzel |
| Correspondent | Mark A Dzendzel SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY Carlsbad, CA 92011 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GHS |
| Subsequent Product Code | GKR |
| Subsequent Product Code | GLY |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| Subsequent Product Code | JPI |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-12 |
| Decision Date | 2008-07-31 |
| Summary: | summary |