The following data is part of a premarket notification filed by Texas Medical Electronics Co. with the FDA for Nocturnal Penile Tumescence Monitor.
| Device ID | K870983 |
| 510k Number | K870983 |
| Device Name: | NOCTURNAL PENILE TUMESCENCE MONITOR |
| Classification | Monitor, Penile Tumescence |
| Applicant | TEXAS MEDICAL ELECTRONICS CO. P.O. BOX 35725 Houston, TX 77235 |
| Contact | Hayati Balkanli |
| Correspondent | Hayati Balkanli TEXAS MEDICAL ELECTRONICS CO. P.O. BOX 35725 Houston, TX 77235 |
| 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 | 1987-03-10 |
| Decision Date | 1987-06-23 |