LF900— 510(k) K231437

Substantially Equivalent

Daesung Maref Co., Ltd.

FDA 510(k) clearance K231437 for LF900, Substantially Equivalent on 2023-07-19. 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: 2023-05-17
Decision date: 2023-07-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

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