FDA 510(k)

AquaFlate プレフィルド無菌水注射器 10mL

K番号: K200556 · 2020-03-31

決定日2020-03-31

製品コードEZL

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてH R Pharmaceuticals, Inc.を記載するその他の記録

K181363EcoVue 無菌および非无菌超音波ジェル

公式ソース

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