MEDICAL LCD MONITOR— 510(k) K141891

Substantially Equivalent

Kostec Co., Ltd.

FDA 510(k) clearance K141891 for MEDICAL LCD MONITOR, Substantially Equivalent on 2014-08-04. Applicant: Kostec Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kostec Co., Ltd.
Product code: Code PGY
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2014-07-14
Decision date: 2014-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

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