The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Dacomed Rigiscan System.
| Device ID | K841202 |
| 510k Number | K841202 |
| Device Name: | DACOMED RIGISCAN SYSTEM |
| Classification | Monitor, Penile Tumescence |
| Applicant | DACOMED CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 | 1984-03-21 |
| Decision Date | 1984-07-06 |