The following data is part of a premarket notification filed by Bci, Inc. with the FDA for Bci Advisor Vital Signs Monitor (9200).
| Device ID | K011177 |
| 510k Number | K011177 |
| Device Name: | BCI ADVISOR VITAL SIGNS MONITOR (9200) |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-17 |
| Decision Date | 2001-05-23 |