FDA 510(k) Premarket Notification K153473: Braemar Telemetry Patch System

Submission Details & Decision

Normalized public record details for 510(k) notification K153473.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K153473

Applicant / Sponsor

Braemar Manufacturing, LLC

Device Name

Braemar Telemetry Patch System

Product Code

DSI

Decision Date

2016-07-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Special

Third Party Flag

Date Received

2015-12-02

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