FDA 510(k)

SQA-iO 精子品質分析儀

K 號：K220828 · 2023-08-07

決定日期2023-08-07

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

SQA-iO Sperm Quality Analyzer 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 2023-08-07 under 510(k) number K220828. 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 SQA-iO Sperm Quality Analyzer?

SQA-iO Sperm Quality Analyzer is a medical device that received FDA 510(k) clearance on 2023-08-07. The listed applicant is Medical Electronic Systems , Ltd.. The 510(k) number is K220828.

When did SQA-iO Sperm Quality Analyzer receive FDA 510(k) clearance?

SQA-iO Sperm Quality Analyzer received FDA 510(k) clearance on 2023-08-07, under 510(k) number K220828.

Who is the listed applicant for SQA-iO Sperm Quality Analyzer?

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 SQA-iO Sperm Quality Analyzer?

The FDA product code for SQA-iO Sperm Quality Analyzer 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 K161493YO 首頁精子檢測

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.K202089LensHooke X1 PRO 精子品質分析儀，LensHooke X1 PRO SE 精子品質分析儀Bonraybio Co., Ltd.

官方來源

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