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FDA 510(k)

LifeLens Wireless ECG Monitor

K-Number: K203168 · 2021-07-20

ApplicantLifeLens Technologies, Inc.
Decision Date2021-07-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LifeLens Wireless ECG Monitor is a medical device manufactured by LifeLens Technologies, Inc.. It received FDA 510(k) clearance on 2021-07-20 under approval number K203168. 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 LifeLens Wireless ECG Monitor?

LifeLens Wireless ECG Monitor is a medical device that received FDA 510(k) clearance on 2021-07-20. It is manufactured by LifeLens Technologies, Inc.. The 510(k) number is K203168.

When was LifeLens Wireless ECG Monitor approved by the FDA?

LifeLens Wireless ECG Monitor received FDA 510(k) clearance on 2021-07-20, under approval number K203168.

What company makes LifeLens Wireless ECG Monitor?

LifeLens Wireless ECG Monitor is manufactured by LifeLens Technologies, Inc..

What is the FDA product code for LifeLens Wireless ECG Monitor?

The FDA product code for LifeLens Wireless ECG Monitor is DSH.

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Official Source

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