EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG— 510(k) K223124

Name: FDA 510(k) clearance K223124
Creator: U.S. Food and Drug Administration
Published: 2022-11-18

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K223124 for EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG, Substantially Equivalent on 2022-11-18. 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: 2022-10-03
Decision date: 2022-11-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Jungwon-Gu, 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.