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FDA 510(k)

Vacutore Air/Water Bottle Tubing

K-Number: K191366 · 2019-09-06

ApplicantSmartdata Suzhou Co., Ltd.
Decision Date2019-09-06
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Vacutore Air/Water Bottle Tubing is a medical device manufactured by Smartdata Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2019-09-06 under approval number K191366. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vacutore Air/Water Bottle Tubing?

Vacutore Air/Water Bottle Tubing is a medical device that received FDA 510(k) clearance on 2019-09-06. It is manufactured by Smartdata Suzhou Co., Ltd.. The 510(k) number is K191366.

When was Vacutore Air/Water Bottle Tubing approved by the FDA?

Vacutore Air/Water Bottle Tubing received FDA 510(k) clearance on 2019-09-06, under approval number K191366.

What company makes Vacutore Air/Water Bottle Tubing?

Vacutore Air/Water Bottle Tubing is manufactured by Smartdata Suzhou Co., Ltd..

What is the FDA product code for Vacutore Air/Water Bottle Tubing?

The FDA product code for Vacutore Air/Water Bottle Tubing is OCX.

Other Devices by Smartdata Suzhou Co., Ltd.

K181509Endorate Valve Sets K191231Andorate Auxiliary Water Connector, Andorate Valves Set K182998Andorate Auxiliary Water Connector

Related Devices (Code: OCX)

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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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