EXPD 4343D; EXPD 3643D— 510(k) K232753

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K232753 for EXPD 4343D; EXPD 3643D, Substantially Equivalent on 2023-11-16. 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: 2023-09-08
Decision date: 2023-11-16
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.