FDA 510(k)

Certa Dose PD 肾上腺素 1mg/mL IM/SC 静脈注射針

K 號：K160589 · 2017-01-19

決定日期2017-01-19

產品代碼PQX

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

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Certa Dose, Inc.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K160589. The device is classified under product code PQX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe?

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Certa Dose, Inc.. The 510(k) number is K160589.

When did Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe receive FDA 510(k) clearance?

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe received FDA 510(k) clearance on 2017-01-19, under 510(k) number K160589.

Who is the listed applicant for Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe?

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

What is the FDA product code for Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe?

The FDA product code for Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe is PQX.

其他以 Certa Dose, 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。

K180683Certa Dose 小兒咪達唑仑 5mg/mL 肌肉注射針筒

相關器械（代碼：PQX）

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。

K180683Certa Dose 小兒咪達唑仑 5mg/mL 肌肉注射針筒Certa Dose, Inc.

官方來源

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