The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem Temperature/ Fio2 Module.
| Device ID | K910381 |
| 510k Number | K910381 |
| Device Name: | BIOCHEM TEMPERATURE/ FIO2 MODULE |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Contact | David A Uhen |
| Correspondent | David A Uhen BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-08-22 |