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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 the device name listed in this FDA 510(k) record. The listed applicant is Braemar Manufacturing, LLC. It received FDA 510(k) clearance on 2016-07-22 under 510(k) 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. The listed applicant is Braemar Manufacturing, LLC. The 510(k) number is K153473.

When did Braemar Telemetry Patch System receive FDA 510(k) clearance?

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

Who is the listed applicant for Braemar Telemetry Patch System?

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

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

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

Other records listing Braemar Manufacturing, 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.

K171410ePatch

Related Devices (Code: DSI)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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