The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for 3304 Pulse Oximeter.
| Device ID | K962156 |
| 510k Number | K962156 |
| Device Name: | 3304 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | BCI INTL., INC. WEST 238, NORTH 1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Contact | Donald J Alexander |
| Correspondent | Donald J Alexander BCI INTL., INC. WEST 238, NORTH 1650 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 | 1996-06-04 |
| Decision Date | 1996-08-28 |
| Summary: | summary |