The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Reusable Finger Sensor 3444.
| Device ID | K974697 |
| 510k Number | K974697 |
| Device Name: | REUSABLE FINGER SENSOR 3444 |
| Classification | Cardiograph, Apex (vibrocardiograph) |
| 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 | DQH |
| CFR Regulation Number | 870.2310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-16 |
| Decision Date | 1998-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517053715 | K974697 | 000 |