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FDA 510(k)

Elvie Stride 2

K-Number: K242125 · 2024-09-27

ApplicantChiaro Technology, Ltd.
Decision Date2024-09-27
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Elvie Stride 2 is a medical device manufactured by Chiaro Technology, Ltd.. It received FDA 510(k) clearance on 2024-09-27 under approval number K242125. 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 Stride 2?

Elvie Stride 2 is a medical device that received FDA 510(k) clearance on 2024-09-27. It is manufactured by Chiaro Technology, Ltd.. The 510(k) number is K242125.

When was Elvie Stride 2 approved by the FDA?

Elvie Stride 2 received FDA 510(k) clearance on 2024-09-27, under approval number K242125.

What company makes Elvie Stride 2?

Elvie Stride 2 is manufactured by Chiaro Technology, Ltd..

What is the FDA product code for Elvie Stride 2?

The FDA product code for Elvie Stride 2 is HGX.

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Official Source

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