The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Pulse Oximeter.
| Device ID | K941289 |
| 510k Number | K941289 |
| Device Name: | PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Contact | Scott J Pease |
| Correspondent | Scott J Pease 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 | 1994-03-17 |
| Decision Date | 1994-06-22 |