OtoSet-耳部清洁系统
K号: K201877 · 2020-11-05
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申请人Safkan, Inc.
决定日期2020-11-05
产品代码KYZ
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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.
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