The following data is part of a premarket notification filed by Sunscope Intl., Inc. with the FDA for Bioport Closed Blood Sampling System, Model Bt Xxxxxx- Bp.
| Device ID | K983372 |
| 510k Number | K983372 |
| Device Name: | BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | SUNSCOPE INTL., INC. 148 SO. 1200 EAST Salt Lake City, UT 84102 |
| Contact | Phil Triolo |
| Correspondent | Phil Triolo SUNSCOPE INTL., INC. 148 SO. 1200 EAST Salt Lake City, UT 84102 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-24 |
| Decision Date | 1999-02-05 |
| Summary: | summary |