Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Dms-Service, LLC. It received FDA 510(k) clearance on 2017-02-22 under 510(k) 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. The listed applicant is Dms-Service, LLC. The 510(k) number is K163535.

When did my Patch sl receive FDA 510(k) clearance?

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

Who is the listed applicant for my Patch sl?

The FDA 510(k) record lists Dms-Service, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for my Patch sl?

The FDA product code for my Patch sl is DSH.

Other records listing Dms-Service, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160704myPatch-s

Related Devices (Code: DSH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens 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.

↑