The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Sensomat.
| Device ID | K803014 |
| 510k Number | K803014 |
| Device Name: | SENSOMAT |
| 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 | 1980-11-28 |
| Decision Date | 1980-12-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SENSOMAT 76580796 3081190 Live/Registered |
Deprag, Inc. 2004-03-11 |
![]() SENSOMAT 72299193 0874236 Dead/Cancelled |
Allied Impex Corp. 1968-05-28 |