EVA (Enhanced Visual Assessment) System— 510(k) K161871

Name: FDA 510(k) clearance K161871
Creator: U.S. Food and Drug Administration
Published: 2016-12-19

Substantially Equivalent

Mobileodt , Ltd.

FDA 510(k) clearance K161871 for EVA (Enhanced Visual Assessment) System, Substantially Equivalent on 2016-12-19. Applicant: Mobileodt , Ltd.. Device class: 2.

Clearance details

Applicant: Mobileodt , Ltd.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2016-07-07
Decision date: 2016-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

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