The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem Model 3301 Newox1 Oximeter.
| Device ID | K920082 |
| 510k Number | K920082 |
| Device Name: | BIOCHEM MODEL 3301 NEWOX1 OXIMETER |
| Classification | Oximeter |
| Applicant | BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53186 |
| Contact | David Uhen |
| Correspondent | David Uhen 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 | 1992-01-07 |
| Decision Date | 1993-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517053689 | K920082 | 000 |
| 35019517042515 | K920082 | 000 |
| 15019517042504 | K920082 | 000 |
| 15019517042498 | K920082 | 000 |