The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for 3301t Oxitemp.
| Device ID | K946185 |
| 510k Number | K946185 |
| Device Name: | 3301T OXITEMP |
| Classification | Oximeter |
| Applicant | BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-03-17 |