The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem Co/ox 1000.
| Device ID | K863186 |
| 510k Number | K863186 |
| Device Name: | BIOCHEM CO/OX 1000 |
| Classification | Oximeter |
| Applicant | BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Contact | Keith R Harper |
| Correspondent | Keith R Harper BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-19 |
| Decision Date | 1986-11-07 |