DVT-2600— 510(k) K203016

Substantially Equivalent

Daesung Maref Co., Ltd.

FDA 510(k) clearance K203016 for DVT-2600, Substantially Equivalent on 2020-12-05. 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: 2020-10-01
Decision date: 2020-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

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