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FDA 510(k)

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)

K-Number: K172011 · 2018-06-14

ApplicantHmicro, Inc.
Decision Date2018-06-14
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) is a medical device manufactured by Hmicro, Inc.. It received FDA 510(k) clearance on 2018-06-14 under approval number K172011. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)?

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Hmicro, Inc.. The 510(k) number is K172011.

When was LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) approved by the FDA?

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) received FDA 510(k) clearance on 2018-06-14, under approval number K172011.

What company makes LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)?

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) is manufactured by Hmicro, Inc..

What is the FDA product code for LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)?

The FDA product code for LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) is DRG.

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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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