EVS 3643, EVS 3643G— 510(k) K162552

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K162552 for EVS 3643, EVS 3643G, Substantially Equivalent on 2016-12-02. Applicant: DRTECH Corporation. Device class: 2.

Clearance details

Applicant: DRTECH Corporation
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2016-09-13
Decision date: 2016-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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