The following data is part of a premarket notification filed by Imagyn Medical Technologies, Inc. with the FDA for Erecaid System/stay Erec System.
| Device ID | K974173 |
| 510k Number | K974173 |
| Device Name: | ERECAID SYSTEM/STAY EREC SYSTEM |
| Classification | Device, External Penile Rigidity |
| Applicant | IMAGYN MEDICAL TECHNOLOGIES, INC. 5 CIVIC PLAZA, SUITE 100 Newport Beach, CA 92660 |
| Contact | Ronald H Bergeson |
| Correspondent | Ronald H Bergeson IMAGYN MEDICAL TECHNOLOGIES, INC. 5 CIVIC PLAZA, SUITE 100 Newport Beach, CA 92660 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-05 |
| Decision Date | 1998-02-25 |
| Summary: | summary |