OtoSet-耳清潔系統
K 號：K201877 · 2020-11-05
廣告
申請人Safkan, Inc.
決定日期2020-11-05
產品代碼KYZ
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
OtoSet- Ear Cleaning System is the device name listed in this FDA 510(k) record. The listed applicant is Safkan, Inc.. It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K201877. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OtoSet- Ear Cleaning System?
OtoSet- Ear Cleaning System is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Safkan, Inc.. The 510(k) number is K201877.
When did OtoSet- Ear Cleaning System receive FDA 510(k) clearance?
OtoSet- Ear Cleaning System received FDA 510(k) clearance on 2020-11-05, under 510(k) number K201877.
Who is the listed applicant for OtoSet- Ear Cleaning System?
The FDA 510(k) record lists Safkan, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OtoSet- Ear Cleaning System?
The FDA product code for OtoSet- Ear Cleaning System is KYZ.
相關臨床試驗
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官方來源
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