The following data is part of a premarket notification filed by Medical Monitoring Systems, Inc. with the FDA for Penile Erection Monitor.
| Device ID | K810944 |
| 510k Number | K810944 |
| Device Name: | PENILE ERECTION MONITOR |
| Classification | Monitor, Penile Tumescence |
| Applicant | MEDICAL MONITORING SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| 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 | 1981-04-07 |
| Decision Date | 1981-04-23 |