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

FDA 510(k)

Braemar Telemetry Patch System

K-Number: K153473 · 2016-07-22

ApplicantBraemar Manufacturing, LLC
Decision Date2016-07-22
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Braemar Telemetry Patch System is a medical device manufactured by Braemar Manufacturing, LLC. It received FDA 510(k) clearance on 2016-07-22 under approval number K153473. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Braemar Telemetry Patch System?

Braemar Telemetry Patch System is a medical device that received FDA 510(k) clearance on 2016-07-22. It is manufactured by Braemar Manufacturing, LLC. The 510(k) number is K153473.

When was Braemar Telemetry Patch System approved by the FDA?

Braemar Telemetry Patch System received FDA 510(k) clearance on 2016-07-22, under approval number K153473.

What company makes Braemar Telemetry Patch System?

Braemar Telemetry Patch System is manufactured by Braemar Manufacturing, LLC.

What is the FDA product code for Braemar Telemetry Patch System?

The FDA product code for Braemar Telemetry Patch System is DSI.

Related Clinical Trials

NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT06164808 Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch RECRUITING NCT06657183 ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy RECRUITING NCT07552805 An Evaluation of Multisense® to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care. NOT_YET_RECRUITING NCT06417853 Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) COMPLETED

Other Devices by Braemar Manufacturing, LLC

K171410ePatch

Related Devices (Code: DSI)

K153477EMMa Electronic Monitoring ManagementVitasystems GmbH K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation K151835Vital Signs Patch SystemLifewatch Technologies , Ltd. K151269ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies , Ltd. K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A.

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.

↑