EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG— 510(k) K192400

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K192400 for EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG, Substantially Equivalent on 2019-10-03. Applicant: DRTECH Corporation.

Clearance details

Applicant: DRTECH Corporation
Product code: Code MQB
Advisory panel: Radiology
Date received: 2019-09-03
Decision date: 2019-10-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Jungwon-Gu, Seongam-Si, KR

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