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FDA 510(k)

Seaman Pro/Seaman

K 號：K252228 · 2026-04-09

申請人Checkcells, Inc.
決定日期2026-04-09
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

Seaman Pro/Seaman is the device name listed in this FDA 510(k) record. The listed applicant is Checkcells, Inc.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K252228. 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 Seaman Pro/Seaman?

Seaman Pro/Seaman is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is Checkcells, Inc.. The 510(k) number is K252228.

When did Seaman Pro/Seaman receive FDA 510(k) clearance?

Seaman Pro/Seaman received FDA 510(k) clearance on 2026-04-09, under 510(k) number K252228.

Who is the listed applicant for Seaman Pro/Seaman?

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

What is the FDA product code for Seaman Pro/Seaman?

The FDA product code for Seaman Pro/Seaman is POV.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

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.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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