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FDA 510(k)

DW-1C

K-Number: K160761 · 2016-11-22

ApplicantDongwon Medical Co., Ltd.
Decision Date2016-11-22
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DW-1C is a medical device manufactured by Dongwon Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-11-22 under approval number K160761. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DW-1C?

DW-1C is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Dongwon Medical Co., Ltd.. The 510(k) number is K160761.

When was DW-1C approved by the FDA?

DW-1C received FDA 510(k) clearance on 2016-11-22, under approval number K160761.

What company makes DW-1C?

DW-1C is manufactured by Dongwon Medical Co., Ltd..

What is the FDA product code for DW-1C?

The FDA product code for DW-1C is NEW.

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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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