The following data is part of a premarket notification filed by Uroan 21 with the FDA for Rigidometer, Model Dir-4u.
| Device ID | K061676 |
| 510k Number | K061676 |
| Device Name: | RIGIDOMETER, MODEL DIR-4U |
| Classification | Monitor, Penile Tumescence |
| Applicant | UROAN 21 12 ANSELM TURMEDA Palma De Mallorca, ES 07003 |
| Contact | Anabel Rossello |
| Correspondent | Anabel Rossello UROAN 21 12 ANSELM TURMEDA Palma De Mallorca, ES 07003 |
| 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 | 2006-06-14 |
| Decision Date | 2006-12-27 |
| Summary: | summary |