The following data is part of a premarket notification filed by Research Industries Corp. with the FDA for Rmi Cirkuit-guard(tm) Pressure Relief Valve.
| Device ID | K945931 |
| 510k Number | K945931 |
| Device Name: | RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | RESEARCH INDUSTRIES CORP. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | H Ibbert |
| Correspondent | H Ibbert RESEARCH INDUSTRIES CORP. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-05 |
| Decision Date | 1995-03-03 |