K000194 is an FDA 510(k) clearance for the DIGITAL INFLECTION RIGIDOMETER (DIR). This device is classified as a Monitor, Penile Tumescence.
Submitted by Uroan Xxi Electromedicina (Baleares, ES). The FDA issued a Cleared decision on April 10, 2000, 80 days after receiving the submission on January 21, 2000.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K000194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2000 |
| Decision Date | April 10, 2000 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LIL — Monitor, Penile Tumescence |
| Device Class | — |