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FDA 510(k)

TEEClean(R) 自动TTE探針清潔消毒器，配備TEEZyme(R)清潔劑及TD-5(R)或TD-8(R)高級消毒劑

K 號：K182891 · 2019-04-12

申請人Cs Medical, LLC
決定日期2019-04-12
產品代碼PSW
諮詢委員會RA
決定相當於

器材摘要

TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants is the device name listed in this FDA 510(k) record. The listed applicant is Cs Medical, LLC. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K182891. The device is classified under product code PSW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants?

TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Cs Medical, LLC. The 510(k) number is K182891.

When did TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants receive FDA 510(k) clearance?

TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants received FDA 510(k) clearance on 2019-04-12, under 510(k) number K182891.

Who is the listed applicant for TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants?

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

What is the FDA product code for TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants?

The FDA product code for TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants is PSW.

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

其他以 Cs Medical, LLC 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。

K233049TD 200®自動TTE探針消毒器，配TD-12®高級消毒劑及QwikCheck™化學指示劑K230381Ethos自動超音波探頭清潔消毒器，配AquaCide清潔劑/高級消毒劑及QwikCheck化學指示劑K192228CS醫療 TD 200 消毒器，配搭 TD-12 高級消毒劑，CS醫療 TD-12 高級消毒劑K160921CS醫療 TD 100 消毒器搭配 TD-5 及 TD-8 高級消毒劑，CS醫療 TD-5 高級消毒劑，CS醫療 TD-8 高級消毒劑

相關器械（代碼：PSW）

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。

K233049TD 200®自動TTE探針消毒器，配TD-12®高級消毒劑及QwikCheck™化學指示劑Cs Medical, LLCK230381Ethos自動超音波探頭清潔消毒器，配AquaCide清潔劑/高級消毒劑及QwikCheck化學指示劑Cs Medical, LLCK192228CS醫療 TD 200 消毒器，配搭 TD-12 高級消毒劑，CS醫療 TD-12 高級消毒劑Cs Medical, LLCK160921CS醫療 TD 100 消毒器搭配 TD-5 及 TD-8 高級消毒劑，CS醫療 TD-5 高級消毒劑，CS醫療 TD-8 高級消毒劑Cs Medical, LLC

官方來源

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