The following data is part of a premarket notification filed by Sunscope Intl., Inc. with the FDA for Biotrans Pressure Monitoring Kit Model Number Bt Xxxxxx.
| Device ID | K981747 |
| 510k Number | K981747 |
| Device Name: | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | SUNSCOPE INTL., INC. 20250 ACACIA ST., SUITE 115 Newport Beach, CA 92660 |
| Contact | John Shulze |
| Correspondent | John Shulze SUNSCOPE INTL., INC. 20250 ACACIA ST., SUITE 115 Newport Beach, CA 92660 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-18 |
| Decision Date | 1998-08-20 |
| Summary: | summary |