The following data is part of a premarket notification filed by Multicept, Aps. with the FDA for Vibrector.
| Device ID | K851646 |
| 510k Number | K851646 |
| Device Name: | VIBRECTOR |
| Classification | Monitor, Penile Tumescence |
| Applicant | MULTICEPT, APS. GENTOFTEGADE 83 2820 GENEOFTE Copenhagen, DK |
| Contact | Jakob Wagner |
| Correspondent | Jakob Wagner MULTICEPT, APS. GENTOFTEGADE 83 2820 GENEOFTE Copenhagen, DK |
| 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 | 1985-04-19 |
| Decision Date | 1985-08-21 |