FDA 510(k)

終端血壓監測器

K 號：K160945 · 2016-09-26

決定日期2016-09-26

產品代碼DSK

諮詢委員會履歷

決定相當於

器材摘要

Endophys Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Endophys Holdings, LLC. It received FDA 510(k) clearance on 2016-09-26 under 510(k) number K160945. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endophys Blood Pressure Monitor?

Endophys Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-09-26. The listed applicant is Endophys Holdings, LLC. The 510(k) number is K160945.

When did Endophys Blood Pressure Monitor receive FDA 510(k) clearance?

Endophys Blood Pressure Monitor received FDA 510(k) clearance on 2016-09-26, under 510(k) number K160945.

Who is the listed applicant for Endophys Blood Pressure Monitor?

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

What is the FDA product code for Endophys Blood Pressure Monitor?

The FDA product code for Endophys Blood Pressure Monitor is DSK.

其他以 Endophys Holdings, LLC 為申請人之記錄

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相關器械（代碼：DSK）

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。

K231586終端血壓監測器型號 BPM-30Endophys Technologies, LLC

官方來源

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