The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Horizon Xvu.
| Device ID | K081484 | 
| 510k Number | K081484 | 
| Device Name: | HORIZON XVU | 
| Classification | Computer, Diagnostic, Programmable | 
| Applicant | MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot, IL 76100 | 
| Contact | Ifat Oren | 
| Correspondent | Ifat Oren MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot, IL 76100 | 
| Product Code | DQK | 
| CFR Regulation Number | 870.1425 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Special | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2008-05-28 | 
| Decision Date | 2008-06-20 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  HORIZON XVU  77167416  3507106 Dead/Cancelled | Mennen Medical Corp. 2007-04-27 |