Zeroveno— 510(k) K192337

Substantially Equivalent

Dimedi Co., Ltd.

FDA 510(k) clearance K192337 for Zeroveno, Substantially Equivalent on 2020-06-22. Applicant: Dimedi Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dimedi Co., Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2019-08-28
Decision date: 2020-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-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.