21HK512D— 510(k) K191864

Substantially Equivalent

Lg Electronics.Inc

FDA 510(k) clearance K191864 for 21HK512D, Substantially Equivalent on 2019-12-05. Applicant: Lg Electronics.Inc. Device class: 2.

Clearance details

Applicant: Lg Electronics.Inc
Product code: Code PGY
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2019-07-12
Decision date: 2019-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek-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.