The following data is part of a premarket notification filed by Bci, Inc. with the FDA for Bci 6004 Nibp Monitor With Nellcor Pulse Oximeter.
| Device ID | K031742 |
| 510k Number | K031742 |
| Device Name: | BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER |
| 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 | 2003-06-04 |
| Decision Date | 2003-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517069419 | K031742 | 000 |
| 08426638170649 | K031742 | 000 |
| 08426638170656 | K031742 | 000 |
| 08426638170663 | K031742 | 000 |
| 08426638170687 | K031742 | 000 |
| 10610586036576 | K031742 | 000 |
| 10610586036583 | K031742 | 000 |
| 10610586036590 | K031742 | 000 |
| 10610586036606 | K031742 | 000 |
| 10610586038334 | K031742 | 000 |
| 08426638163108 | K031742 | 000 |