FDA 510(k)

YO 首頁精子檢測

K 號：K161493 · 2016-11-08

決定日期2016-11-08

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

YO Home Sperm Test is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronic Systems , Ltd.. It received FDA 510(k) clearance on 2016-11-08 under 510(k) number K161493. 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 YO Home Sperm Test?

YO Home Sperm Test is a medical device that received FDA 510(k) clearance on 2016-11-08. The listed applicant is Medical Electronic Systems , Ltd.. The 510(k) number is K161493.

When did YO Home Sperm Test receive FDA 510(k) clearance?

YO Home Sperm Test received FDA 510(k) clearance on 2016-11-08, under 510(k) number K161493.

Who is the listed applicant for YO Home Sperm Test?

The FDA 510(k) record lists Medical Electronic Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YO Home Sperm Test?

The FDA product code for YO Home Sperm Test is POV.

其他以 Medical Electronic Systems , Ltd. 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。

K243114SQA-iOw 精子品質分析儀 K241628YO 首頁精子檢測 K220828SQA-iO 精子品質分析儀

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。

K252228Seaman Pro/SeamanCheckcells, Inc.K242830LensHooke X3 PRO 精子品質分析儀；LensHooke X3 PRO SE 精子品質分析儀Bonraybio Co., Ltd.K242388鏡鎚X12 PRO 精子分析系統Bonraybio Co., Ltd.K243114SQA-iOw 精子品質分析儀Medical Electronic Systems , Ltd.K241628YO 首頁精子檢測Medical Electronic Systems , Ltd.K220828SQA-iO 精子品質分析儀Medical Electronic Systems , Ltd.

官方來源

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