FDA 510(k)

Elvie Pump

K-Number: K181863 · 2018-10-10

Decision Date2018-10-10

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Elvie Pump is a medical device manufactured by Chiaro Technology Limited. It received FDA 510(k) clearance on 2018-10-10 under approval number K181863. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elvie Pump?

Elvie Pump is a medical device that received FDA 510(k) clearance on 2018-10-10. It is manufactured by Chiaro Technology Limited. The 510(k) number is K181863.

When was Elvie Pump approved by the FDA?

Elvie Pump received FDA 510(k) clearance on 2018-10-10, under approval number K181863.

What company makes Elvie Pump?

Elvie Pump is manufactured by Chiaro Technology Limited.

What is the FDA product code for Elvie Pump?

The FDA product code for Elvie Pump is HGX.

Other Devices by Chiaro Technology Limited

K210936Elvie Stride

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.