The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Cavernosometry Module For Menuet.
| Device ID | K923117 |
| 510k Number | K923117 |
| Device Name: | CAVERNOSOMETRY MODULE FOR MENUET |
| Classification | Device, Erectile Dysfunction |
| Applicant | DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Richard D Manthei |
| Correspondent | Richard D Manthei DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | LST |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-26 |
| Decision Date | 1993-02-22 |