The following data is part of a premarket notification filed by Uroan Xxi Electromedicina with the FDA for Digital Inflection Rigidometer (dir).
| Device ID | K000194 |
| 510k Number | K000194 |
| Device Name: | DIGITAL INFLECTION RIGIDOMETER (DIR) |
| Classification | Monitor, Penile Tumescence |
| Applicant | UROAN XXI ELECTROMEDICINA C/ ANSELM TURMEDA, 12 PALMA DE MALLORCA Baleares, ES 07003 |
| Contact | Victoria Gaya |
| Correspondent | Victoria Gaya UROAN XXI ELECTROMEDICINA C/ ANSELM TURMEDA, 12 PALMA DE MALLORCA Baleares, 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 | 2000-01-21 |
| Decision Date | 2000-04-10 |