The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for 6200 Vital Signs Monitor.
| Device ID | K953415 |
| 510k Number | K953415 |
| Device Name: | 6200 VITAL SIGNS MONITOR |
| Classification | Electrocardiograph |
| Applicant | BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Contact | Donal Alexander |
| Correspondent | Donal Alexander BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha, WI 53188 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-20 |
| Decision Date | 1995-10-19 |