Submission Details
| 510(k) Number | K091165 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 22, 2009 |
| Decision Date | August 07, 2009 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
K091165 - HORIZON XVU
(FDA 510(k) Clearance)
Aug 2009
Decision
107d
Days
Class 2
Risk
K091165 is an FDA 510(k) clearance for the HORIZON XVU, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Mennen Medical , Ltd. (Rohovot, IL). The FDA issued a Cleared decision on August 7, 2009, 107 days after receiving the submission on April 22, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.
Device Classification
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1425 |
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