LX9max— 510(k) K203498

Substantially Equivalent

Daesung Maref Co., Ltd.

FDA 510(k) clearance K203498 for LX9max, Substantially Equivalent on 2021-07-02. Applicant: Daesung Maref Co., Ltd.. Device class: 2.

Clearance details

Applicant: Daesung Maref Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2020-11-27
Decision date: 2021-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

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