FLAATZ 560— 510(k) K111583

Substantially Equivalent

Drtech Corp.

FDA 510(k) clearance K111583 for FLAATZ 560, Substantially Equivalent on 2011-10-04. 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: 2011-06-07
Decision date: 2011-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Seongnam-Shi, Gyeonggi-Do, 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.