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FDA 510(k)

IBP傳感器轉接線，氩/BD/Ohmeda，2m；IBP傳感器轉接線，Draeger 10-pin，2m；IBP傳感器轉接線，Draeger 7-pin，2m；IBP傳感器轉接線，Abbott/Medex，Smiths/TranStar 2m；IBP傳感器轉接線，Baxter/Edwards，0.3m；IBP傳感器轉接線，Argon/BD/Ohmeda，0.3m；IBP傳感器轉接線，Draeger 10-pin，0.3m；IBP傳感器轉接線，Draeger 7-pin，0.3m；IBP傳感器轉接線

K 號：K251669 · 2025-09-30

申請人Shanghai Draeger Medical Instrument Co., Ltd.
決定日期2025-09-30
產品代碼DSA
諮詢委員會履歷
決定相當於

器材摘要

IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Draeger Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-09-30 under 510(k) number K251669. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter?

IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter is a medical device that received FDA 510(k) clearance on 2025-09-30. The listed applicant is Shanghai Draeger Medical Instrument Co., Ltd.. The 510(k) number is K251669.

When did IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter receive FDA 510(k) clearance?

IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter received FDA 510(k) clearance on 2025-09-30, under 510(k) number K251669.

Who is the listed applicant for IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter?

The FDA 510(k) record lists Shanghai Draeger Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter?

The FDA product code for IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter is DSA.

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。

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其他以 Shanghai Draeger Medical Instrument Co., 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。

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相關器械（代碼：DSA）

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。

K254114貝利斯連接線Baylis Medical Technologies, Inc.K252827IBP纜線 Becton Dickinson (2606488)；IBP纜線 Edwards (2606489)；IBP纜線 Abbott, Medex (2606490)；IBP纜線 Utah (2606491)；IBP轉接纜線 Draeger 7針 (2607558)；IBP轉接纜線 Draeger 10針 (2607559)Drägerwerk AG & Co. KGaAK242986SpO2 延長線Beijing Rongrui-Century Science & Technology Co., Ltd.K243545飛利浦可重用心電圖導联組及樹幹電纜：型號編號、型號名稱：989803170171，或3導心電樹幹電纜，AAMI/IEC；989803170181，或5導心電樹幹電纜，AAMI/IEC；M1667A，6導心電樹幹，AAMI/IEC 2.7m；M1668A，5導心電樹幹，AAMI/IEC 2.7m；M1669A，3導心電樹幹，AAMI/IEC 2.7m；M1949A，5+5心電樹幹電纜 AAMI，IEC 2.7m；M1663A，10導心電樹幹 AAMI/IEC 2m；M1665A，6+4導心電樹幹 AAMI/IEC 2.7m；M1671A，3導聯組，抓取器，AAMI，ICU；M1673A，3導聯組，SnPhilips Medizin Systeme Böblingen GmbHK240087RT碳電極心電圖Ivy Biomedical Systems, Inc.K240377LIFEPAK® 心電圖電纜Stryker Physio-Control

官方來源

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