The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Bci Model 6004 Nibp Monitor (6004).
| Device ID | K970801 |
| 510k Number | K970801 |
| Device Name: | BCI MODEL 6004 NIBP MONITOR (6004) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Contact | Donald J Alexander |
| Correspondent | Donald J Alexander BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-11-12 |
| Summary: | summary |