FDA 510(k)

AquaFlate 預充无菌水針筒 10mL

K 號：K200556 · 2020-03-31

決定日期2020-03-31

產品代碼EZL

諮詢委員會GU

決定相當於

器材摘要

AquaFlate Pre-Filled Sterile Water Syringe 10mL is the device name listed in this FDA 510(k) record. The listed applicant is H R Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K200556. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AquaFlate Pre-Filled Sterile Water Syringe 10mL?

AquaFlate Pre-Filled Sterile Water Syringe 10mL is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is H R Pharmaceuticals, Inc.. The 510(k) number is K200556.

When did AquaFlate Pre-Filled Sterile Water Syringe 10mL receive FDA 510(k) clearance?

AquaFlate Pre-Filled Sterile Water Syringe 10mL received FDA 510(k) clearance on 2020-03-31, under 510(k) number K200556.

Who is the listed applicant for AquaFlate Pre-Filled Sterile Water Syringe 10mL?

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

What is the FDA product code for AquaFlate Pre-Filled Sterile Water Syringe 10mL?

The FDA product code for AquaFlate Pre-Filled Sterile Water Syringe 10mL is EZL.

其他以 H R Pharmaceuticals, 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。

K181363EcoVue 無菌及非无菌超音波膠

相關器械（代碼：EZL）

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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