Submission Details
| 510(k) Number | K110597 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 02, 2011 |
| Decision Date | June 14, 2011 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
EV1000 CLINICAL PLATFORM
Jun 2011
Decision
104d
Days
Class 2
Risk
About This 510(k) Submission
K110597 is an FDA 510(k) clearance for the EV1000 CLINICAL PLATFORM, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on June 14, 2011, 104 days after receiving the submission on March 2, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.
Device Classification
| Product Code | DXG — Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1435 |
Manufacturer
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