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FDA 510(k)

Andorate Auxiliary Water Connector, Andorate Valves Set

K-Number: K191231 · 2019-06-07

ApplicantSmartdata Suzhou Co., Ltd.
Decision Date2019-06-07
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Andorate Auxiliary Water Connector, Andorate Valves Set is a medical device manufactured by Smartdata Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2019-06-07 under approval number K191231. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Andorate Auxiliary Water Connector, Andorate Valves Set?

Andorate Auxiliary Water Connector, Andorate Valves Set is a medical device that received FDA 510(k) clearance on 2019-06-07. It is manufactured by Smartdata Suzhou Co., Ltd.. The 510(k) number is K191231.

When was Andorate Auxiliary Water Connector, Andorate Valves Set approved by the FDA?

Andorate Auxiliary Water Connector, Andorate Valves Set received FDA 510(k) clearance on 2019-06-07, under approval number K191231.

What company makes Andorate Auxiliary Water Connector, Andorate Valves Set?

Andorate Auxiliary Water Connector, Andorate Valves Set is manufactured by Smartdata Suzhou Co., Ltd..

What is the FDA product code for Andorate Auxiliary Water Connector, Andorate Valves Set?

The FDA product code for Andorate Auxiliary Water Connector, Andorate Valves Set is ODC.

Other Devices by Smartdata Suzhou Co., Ltd.

K181509Endorate Valve Sets K191366Vacutore Air/Water Bottle Tubing K182998Andorate Auxiliary Water Connector

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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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