VICOR PD2I ANALYZER, VERSION 2.1— 510(k) K082709

Substantially Equivalent

Vicor Technologies, Inc.

FDA 510(k) clearance K082709 for VICOR PD2I ANALYZER, VERSION 2.1, Substantially Equivalent on 2008-12-29. Applicant: Vicor Technologies, Inc..

Clearance details

Applicant: Vicor Technologies, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2008-09-16
Decision date: 2008-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.