The following data is part of a premarket notification filed by Sunscope Intl., Inc. with the FDA for Safewedge(tm) Relief Valve Device.
| Device ID | K912172 |
| 510k Number | K912172 |
| Device Name: | SAFEWEDGE(TM) RELIEF VALVE DEVICE |
| Classification | Probe, Thermodilution |
| Applicant | SUNSCOPE INTL., INC. 1775 SHAWNESS COURT Westlake Village, CA 91362 |
| Contact | Keith Chan |
| Correspondent | Keith Chan SUNSCOPE INTL., INC. 1775 SHAWNESS COURT Westlake Village, CA 91362 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-16 |
| Decision Date | 1991-09-27 |