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FDA 510(k)

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector

K-Number: K200388 · 2020-04-14

ApplicantGa Health Company Limited
Decision Date2020-04-14
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is a medical device manufactured by Ga Health Company Limited. It received FDA 510(k) clearance on 2020-04-14 under approval number K200388. 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 CO2 Tubing with Luer Connector?

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is a medical device that received FDA 510(k) clearance on 2020-04-14. It is manufactured by Ga Health Company Limited. The 510(k) number is K200388.

When was Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector approved by the FDA?

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector received FDA 510(k) clearance on 2020-04-14, under approval number K200388.

What company makes Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is manufactured by Ga Health Company Limited.

What is the FDA product code for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

The FDA product code for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is 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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