Oryum與Ovem表皮皮膚針刺試驗應用器
K 號：K182582 · 2019-04-10
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決定日期2019-04-10
產品代碼SCL
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
Oryum and Ovem Epidermal Deri Prick Test Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Allergy & Applicator Depot, LLC. It received FDA 510(k) clearance on 2019-04-10 under 510(k) number K182582. The device is classified under product code SCL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Oryum and Ovem Epidermal Deri Prick Test Applicator?
Oryum and Ovem Epidermal Deri Prick Test Applicator is a medical device that received FDA 510(k) clearance on 2019-04-10. The listed applicant is Allergy & Applicator Depot, LLC. The 510(k) number is K182582.
When did Oryum and Ovem Epidermal Deri Prick Test Applicator receive FDA 510(k) clearance?
Oryum and Ovem Epidermal Deri Prick Test Applicator received FDA 510(k) clearance on 2019-04-10, under 510(k) number K182582.
Who is the listed applicant for Oryum and Ovem Epidermal Deri Prick Test Applicator?
The FDA 510(k) record lists Allergy & Applicator Depot, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Oryum and Ovem Epidermal Deri Prick Test Applicator?
The FDA product code for Oryum and Ovem Epidermal Deri Prick Test Applicator is SCL.
相關臨床試驗
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相關器械（代碼：SCL）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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