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FDA 510(k)

AquaPulse Auxiliary Water Connector

K-Number: K200479 · 2020-05-15

ApplicantGa Health Company Limited
Decision Date2020-05-15
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AquaPulse Auxiliary Water Connector is a medical device manufactured by Ga Health Company Limited. It received FDA 510(k) clearance on 2020-05-15 under approval number K200479. 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 AquaPulse Auxiliary Water Connector?

AquaPulse Auxiliary Water Connector is a medical device that received FDA 510(k) clearance on 2020-05-15. It is manufactured by Ga Health Company Limited. The 510(k) number is K200479.

When was AquaPulse Auxiliary Water Connector approved by the FDA?

AquaPulse Auxiliary Water Connector received FDA 510(k) clearance on 2020-05-15, under approval number K200479.

What company makes AquaPulse Auxiliary Water Connector?

AquaPulse Auxiliary Water Connector is manufactured by Ga Health Company Limited.

What is the FDA product code for AquaPulse Auxiliary Water Connector?

The FDA product code for AquaPulse Auxiliary Water 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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