EVS 4343, EVS 4343G— 510(k) K162555

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K162555 for EVS 4343, EVS 4343G, Substantially Equivalent on 2016-12-21. Applicant: DRTECH Corporation.

Clearance details

Applicant: DRTECH Corporation
Product code: Code MQB
Advisory panel: Radiology
Date received: 2016-09-13
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Seongnam-Si, KR

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