The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Tumisensor 1524.
| Device ID | K831251 |
| 510k Number | K831251 |
| Device Name: | TUMISENSOR 1524 |
| Classification | Monitor, Penile Tumescence |
| Applicant | LIFE-TECH INTL., 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 | 1983-04-18 |
| Decision Date | 1983-06-03 |