The following data is part of a premarket notification filed by Laborie Medical Tech Corp. with the FDA for Viser Penile Tumescence Monitor.
| Device ID | K991479 |
| 510k Number | K991479 |
| Device Name: | VISER PENILE TUMESCENCE MONITOR |
| Classification | Monitor, Penile Tumescence |
| Applicant | LABORIE MEDICAL TECH CORP. 310 HURRICANE LN. #2 Williston, VT 05495 |
| Contact | Dale Coleman |
| Correspondent | Dale Coleman LABORIE MEDICAL TECH CORP. 310 HURRICANE LN. #2 Williston, VT 05495 |
| 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 | 1999-04-28 |
| Decision Date | 1999-07-07 |