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FDA 510(k)

eWave Monitor

K-Number: K214073 · 2022-10-20

ApplicantWearlinq, Inc.
Decision Date2022-10-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

eWave Monitor is a medical device manufactured by Wearlinq, Inc.. It received FDA 510(k) clearance on 2022-10-20 under approval number K214073. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eWave Monitor?

eWave Monitor is a medical device that received FDA 510(k) clearance on 2022-10-20. It is manufactured by Wearlinq, Inc.. The 510(k) number is K214073.

When was eWave Monitor approved by the FDA?

eWave Monitor received FDA 510(k) clearance on 2022-10-20, under approval number K214073.

What company makes eWave Monitor?

eWave Monitor is manufactured by Wearlinq, Inc..

What is the FDA product code for eWave Monitor?

The FDA product code for eWave Monitor is DSH.

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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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