The following data is part of a premarket notification filed by Behavioral Technology, Inc. with the FDA for Monarch 21 Penile Plethysmograph System.
| Device ID | K033126 |
| 510k Number | K033126 |
| Device Name: | MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM |
| Classification | Monitor, Penile Tumescence |
| Applicant | BEHAVIORAL TECHNOLOGY, INC. 24 M ST., #1 Salt Lake City, UT 84103 |
| Contact | Susan E Olsen |
| Correspondent | Susan E Olsen BEHAVIORAL TECHNOLOGY, INC. 24 M ST., #1 Salt Lake City, UT 84103 |
| Product Code | LIL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2003-10-29 |
| Summary: | summary |