The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Vital Signs Monitor; Advisor Model # Bci 9200.
| Device ID | K982279 |
| 510k Number | K982279 |
| Device Name: | VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-30 |
| Decision Date | 1998-09-25 |
| Summary: | summary |