The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Dacomed Snap-gauge.
| Device ID | K832121 |
| 510k Number | K832121 |
| Device Name: | DACOMED SNAP-GAUGE |
| Classification | Monitor, Penile Tumescence |
| Applicant | DACOMED CORP. MD |
| 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 | 1983-06-30 |
| Decision Date | 1983-07-18 |