The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Aortic Root/coronary Sinus Pressure Monitoring.
| Device ID | K897137 |
| 510k Number | K897137 |
| Device Name: | RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
| Contact | Michael N Kelly |
| Correspondent | Michael N Kelly RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-27 |
| Decision Date | 1990-03-27 |