The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Bci Mini-torr Plus, Model 6004.
| Device ID | K984618 |
| 510k Number | K984618 |
| Device Name: | BCI MINI-TORR PLUS, MODEL 6004 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BCI INTL., INC. N7 W22025 JOHNSON RD. Waukesha, WI 53186 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander BCI INTL., INC. N7 W22025 JOHNSON RD. Waukesha, WI 53186 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-29 |
| Decision Date | 1999-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517057737 | K984618 | 000 |
| 15019517043082 | K984618 | 000 |
| 15019517043075 | K984618 | 000 |