The following data is part of a premarket notification filed by Plethora Solutions with the FDA for Plethora Solutions Sexual Assessment Monitor (sam).
| Device ID | K062042 |
| 510k Number | K062042 |
| Device Name: | PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) |
| Classification | Monitor, Penile Tumescence |
| Applicant | PLETHORA SOLUTIONS 54 FOREST STREET Lexington, MA 02421 |
| Contact | Kimberley Doney |
| Correspondent | Kimberley Doney PLETHORA SOLUTIONS 54 FOREST STREET Lexington, MA 02421 |
| Product Code | LIL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-19 |
| Decision Date | 2006-09-06 |
| Summary: | summary |