FLAATZ 600 SERIES (FLAATZ 600/601)— 510(k) K132842

Name: FDA 510(k) clearance K132842
Creator: U.S. Food and Drug Administration
Published: 2014-02-21

Substantially Equivalent

Drtech Corp.

FDA 510(k) clearance K132842 for FLAATZ 600 SERIES (FLAATZ 600/601), Substantially Equivalent on 2014-02-21. Applicant: Drtech Corp.. Device class: 2.

Clearance details

Applicant: Drtech Corp.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2013-09-10
Decision date: 2014-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Seongnam-Shi, Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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