DVT-4000S— 510(k) K203417

Substantially Equivalent

Daesung Maref Co., Ltd.

FDA 510(k) clearance K203417 for DVT-4000S, Substantially Equivalent on 2021-03-28. Applicant: Daesung Maref Co., Ltd.. Device class: 2.

Clearance details

Applicant: Daesung Maref Co., Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2020-11-19
Decision date: 2021-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

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