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FDA 510(k)

my Patch sl

K-Number: K163535 · 2017-02-22

ApplicantDms-Service, LLC
Decision Date2017-02-22
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

my Patch sl is a medical device manufactured by Dms-Service, LLC. It received FDA 510(k) clearance on 2017-02-22 under approval number K163535. 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 my Patch sl?

my Patch sl is a medical device that received FDA 510(k) clearance on 2017-02-22. It is manufactured by Dms-Service, LLC. The 510(k) number is K163535.

When was my Patch sl approved by the FDA?

my Patch sl received FDA 510(k) clearance on 2017-02-22, under approval number K163535.

What company makes my Patch sl?

my Patch sl is manufactured by Dms-Service, LLC.

What is the FDA product code for my Patch sl?

The FDA product code for my Patch sl is DSH.

Other Devices by Dms-Service, LLC

K160704myPatch-s

Related Devices (Code: DSH)

K162571Bioflux SoftwareBiotricity, Inc. K160704myPatch-sDms-Service, LLC K171936Peerbridge Cor(TM) SystemPeerbridge Health, Inc. K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc. K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL K172862Portable ECG Monitor (ECG3)Andon Health Co, Ltd.

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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