The following data is part of a premarket notification filed by Bci, Inc. with the FDA for Bci 3178 Pediatric Pulse Oximetry Sensor.
| Device ID | K020739 |
| 510k Number | K020739 |
| Device Name: | BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR |
| Classification | Oximeter |
| Applicant | BCI, INC. N7 W22025 JOHNSON RD. Waukesha, WI 53186 |
| Contact | Donald J Alexander |
| Correspondent | Donald J 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 | 2002-03-06 |
| Decision Date | 2002-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30843418001099 | K020739 | 000 |
| 15019517043037 | K020739 | 000 |