The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Sensomat Muscle/tissue Ph.
| Device ID | K803260 |
| 510k Number | K803260 |
| Device Name: | SENSOMAT MUSCLE/TISSUE PH |
| Classification | Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling |
| Applicant | BIOCHEM INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBZ |
| CFR Regulation Number | 868.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-24 |
| Decision Date | 1981-02-02 |