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FDA 510(k)

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

K-Number: K181541 · 2019-04-16

ApplicantAndon Health Co, Ltd.
Decision Date2019-04-16
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2019-04-16 under approval number K181541. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK?

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK is a medical device that received FDA 510(k) clearance on 2019-04-16. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K181541.

When was Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK approved by the FDA?

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK received FDA 510(k) clearance on 2019-04-16, under approval number K181541.

What company makes Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK?

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK is manufactured by Andon Health Co, Ltd..

What is the FDA product code for Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK?

The FDA product code for Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK is MWI.

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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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