德瑪治療床單
K 號：K152884 · 2016-06-20
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決定日期2016-06-20
產品代碼FMW
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
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.
常見問題
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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官方來源
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