The following data is part of a premarket notification filed by Compass Medical Technologies, Inc. with the FDA for Rt2 Rigidity And Tumescence Test.
| Device ID | K925931 |
| 510k Number | K925931 |
| Device Name: | RT2 RIGIDITY AND TUMESCENCE TEST |
| Classification | Monitor, Penile Tumescence |
| Applicant | COMPASS MEDICAL TECHNOLOGIES, INC. 5005 BRYANT AVE. S. SUITE 110 Minneapolis, MN 55419 |
| Contact | Philip L Brooks |
| Correspondent | Philip L Brooks COMPASS MEDICAL TECHNOLOGIES, INC. 5005 BRYANT AVE. S. SUITE 110 Minneapolis, MN 55419 |
| Product Code | LIL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-23 |
| Decision Date | 1992-12-21 |