K062042 is an FDA 510(k) clearance for the PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM). This device is classified as a Monitor, Penile Tumescence.
Submitted by Plethora Solutions (Lexington, US). The FDA issued a Cleared decision on September 6, 2006, 49 days after receiving the submission on July 19, 2006.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K062042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2006 |
| Decision Date | September 06, 2006 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LIL — Monitor, Penile Tumescence |
| Device Class | — |