K033126 is an FDA 510(k) clearance for the MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM. This device is classified as a Monitor, Penile Tumescence.
Submitted by Behavioral Technology, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 29, 2003, 29 days after receiving the submission on September 30, 2003.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K033126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2003 |
| Decision Date | October 29, 2003 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LIL — Monitor, Penile Tumescence |
| Device Class | — |