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FDA 510(k)

DVT-PRO

K-Number: K203353 · 2021-04-22

ApplicantDaesung Maref Co., Ltd.
Decision Date2021-04-22
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DVT-PRO is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2021-04-22 under 510(k) number K203353. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DVT-PRO?

DVT-PRO is a medical device that received FDA 510(k) clearance on 2021-04-22. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K203353.

When did DVT-PRO receive FDA 510(k) clearance?

DVT-PRO received FDA 510(k) clearance on 2021-04-22, under 510(k) number K203353.

Who is the listed applicant for DVT-PRO?

The FDA 510(k) record lists Daesung Maref Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DVT-PRO?

The FDA product code for DVT-PRO is JOW.

Other records listing Daesung Maref Co., Ltd. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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