DermaTherapy 床单
K号: K152884 · 2016-06-20
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决定日期2016-06-20
产品代码FMW
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
DermaTherapy Bed Linens is the device name listed in this FDA 510(k) record. The listed applicant is Precision Fabrics Group, Inc.. It received FDA 510(k) clearance on 2016-06-20 under 510(k) number K152884. The device is classified under product code FMW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DermaTherapy Bed Linens?
DermaTherapy Bed Linens is a medical device that received FDA 510(k) clearance on 2016-06-20. The listed applicant is Precision Fabrics Group, Inc.. The 510(k) number is K152884.
When did DermaTherapy Bed Linens receive FDA 510(k) clearance?
DermaTherapy Bed Linens received FDA 510(k) clearance on 2016-06-20, under 510(k) number K152884.
Who is the listed applicant for DermaTherapy Bed Linens?
The FDA 510(k) record lists Precision Fabrics Group, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DermaTherapy Bed Linens?
The FDA product code for DermaTherapy Bed Linens is FMW.
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官方来源
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