The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for 6004 Nibp Monitor With Temperature.
| Device ID | K983796 |
| 510k Number | K983796 |
| Device Name: | 6004 NIBP MONITOR WITH TEMPERATURE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BCI INTL., INC. N7 W22025 JOHNSON RD. Waukesha, WI 53186 |
| Contact | Donald J Alexander |
| Correspondent | Donald J Alexander BCI INTL., INC. N7 W22025 JOHNSON RD. Waukesha, WI 53186 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-27 |
| Decision Date | 1999-01-22 |
| Summary: | summary |