EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP— 510(k) K193017

Name: FDA 510(k) clearance K193017
Creator: U.S. Food and Drug Administration
Published: 2019-11-22

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K193017 for EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP, Substantially Equivalent on 2019-11-22. 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: 2019-10-29
Decision date: 2019-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Jungwon-Gu, Seongam-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.