FLAATZ 500— 510(k) K091747

Name: FDA 510(k) clearance K091747
Creator: U.S. Food and Drug Administration
Published: 2009-07-01

Substantially Equivalent

Drtech Corp.

FDA 510(k) clearance K091747 for FLAATZ 500, Substantially Equivalent on 2009-07-01. Applicant: Drtech Corp.. Device class: 2.

Clearance details

Applicant: Drtech Corp.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2009-06-16
Decision date: 2009-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Shi, Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.