The following data is part of a premarket notification filed by Bci, Inc. with the FDA for Bci 3403 Sleep Screening Pulse Oximeter.
| Device ID | K011156 |
| 510k Number | K011156 |
| Device Name: | BCI 3403 SLEEP SCREENING PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | BCI, INC. N7 W22025 JOHNSON RD. Waukesha, WI 53186 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander BCI, INC. N7 W22025 JOHNSON RD. 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 | 2001-04-16 |
| Decision Date | 2001-06-14 |