FDA 510(k)

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K 號：K153473 · 2016-07-22

決定日期2016-07-22

產品代碼DSI

諮詢委員會履歷

決定相當於

器材摘要

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.

常見問題

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.

其他以 Braemar Manufacturing, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K171410ePatch

相關器械（代碼：DSI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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