K061676 is an FDA 510(k) clearance for the RIGIDOMETER, MODEL DIR-4U. This device is classified as a Monitor, Penile Tumescence.
Submitted by Uroan 21 (Palma De Mallorca, ES). The FDA issued a Cleared decision on December 27, 2006, 196 days after receiving the submission on June 14, 2006.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K061676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2006 |
| Decision Date | December 27, 2006 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LIL — Monitor, Penile Tumescence |
| Device Class | — |