The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Rigiscan Plus Rigidity Assessment System.
| Device ID | K941781 |
| 510k Number | K941781 |
| Device Name: | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM |
| Classification | Monitor, Penile Tumescence |
| Applicant | DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Contact | Mary M Wilen |
| Correspondent | Mary M Wilen DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| 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 | 1994-04-11 |
| Decision Date | 1994-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854759007059 | K941781 | 000 |
| 00854759007014 | K941781 | 000 |
| 00854759007021 | K941781 | 000 |
| 00854759007038 | K941781 | 000 |
| 00854759007045 | K941781 | 000 |
| 00854759007052 | K941781 | 000 |
| 00854759007069 | K941781 | 000 |
| 00854759007076 | K941781 | 000 |
| 00854759007083 | K941781 | 000 |
| 00854759007090 | K941781 | 000 |
| 00854759007106 | K941781 | 000 |
| 10854759007042 | K941781 | 000 |
| 00854759007007 | K941781 | 000 |