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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 the device name listed in this FDA 510(k) record. The listed applicant is Chiaro Technology, Ltd.. It received FDA 510(k) clearance on 2024-09-27 under 510(k) 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. The listed applicant is Chiaro Technology, Ltd.. The 510(k) number is K242125.

When did Elvie Stride 2 receive FDA 510(k) clearance?

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

Who is the listed applicant for Elvie Stride 2?

The FDA 510(k) record lists Chiaro Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elvie Stride 2?

The FDA product code for Elvie Stride 2 is HGX.

Other records listing Chiaro Technology, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210936Elvie StrideK181863Elvie Pump

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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