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FDA 510(k)

CADD®-索利斯外用輸液泵，配無線通訊功能；CADD®-索利斯輸液泵，型號2110；PharmGuard®管理員藥物安全軟件；CADD®管理套件；無線通訊模組（CM）

K 號：K170982 · 2017-08-24

申請人Smiths Medical Ads, Inc.
決定日期2017-08-24
產品代碼MEA
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Ads, Inc.. It received FDA 510(k) clearance on 2017-08-24 under 510(k) number K170982. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)?

CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) is a medical device that received FDA 510(k) clearance on 2017-08-24. The listed applicant is Smiths Medical Ads, Inc.. The 510(k) number is K170982.

When did CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) receive FDA 510(k) clearance?

CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) received FDA 510(k) clearance on 2017-08-24, under 510(k) number K170982.

Who is the listed applicant for CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)?

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

What is the FDA product code for CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)?

The FDA product code for CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) is MEA.

相關臨床試驗

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其他以 Smiths Medical Ads, Inc. 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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官方來源

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