GEMS-H— 510(k) K213452

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K213452 for GEMS-H, Substantially Equivalent on 2022-04-21. Applicant: Samsung Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code PHL
Device class: Class 2
Regulation: 21 CFR 890.3480
Advisory panel: Physical Medicine
Date received: 2021-10-26
Decision date: 2022-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-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.