The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem 3100 Oximeter.
| Device ID | K893877 |
| 510k Number | K893877 |
| Device Name: | BIOCHEM 3100 OXIMETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Contact | Keith Harper |
| Correspondent | Keith Harper BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-26 |
| Decision Date | 1989-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517053696 | K893877 | 000 |
| 35019517042584 | K893877 | 000 |
| 35019517042577 | K893877 | 000 |
| 35019517042560 | K893877 | 000 |
| 15019517042559 | K893877 | 000 |
| 15019517042542 | K893877 | 000 |