FDA 510(k)

Trak男性生育檢測系統

K 號：K153683 · 2016-05-16

決定日期2016-05-16

產品代碼POV

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

Trak Male Fertility Testing System is the device name listed in this FDA 510(k) record. The listed applicant is Sandstone Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-05-16 under 510(k) number K153683. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Trak Male Fertility Testing System?

Trak Male Fertility Testing System is a medical device that received FDA 510(k) clearance on 2016-05-16. The listed applicant is Sandstone Diagnostics, Inc.. The 510(k) number is K153683.

When did Trak Male Fertility Testing System receive FDA 510(k) clearance?

Trak Male Fertility Testing System received FDA 510(k) clearance on 2016-05-16, under 510(k) number K153683.

Who is the listed applicant for Trak Male Fertility Testing System?

The FDA 510(k) record lists Sandstone Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trak Male Fertility Testing System?

The FDA product code for Trak Male Fertility Testing System is POV.

其他以 Sandstone Diagnostics, Inc. 為申請人之記錄

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K172514Trak Plus 男性生育檢測系統

相關器械（代碼：POV）

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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