EVS 3643— 510(k) K151942

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K151942 for EVS 3643, Substantially Equivalent on 2015-10-21. 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: 2015-07-14
Decision date: 2015-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
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.