DESCRIBE PFD 贴片
K号: K172689 · 2017-11-29
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决定日期2017-11-29
产品代码PKO
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
DESCRIBE PFD Patch is the device name listed in this FDA 510(k) record. The listed applicant is Merz North America, Inc.. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172689. The device is classified under product code PKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DESCRIBE PFD Patch?
DESCRIBE PFD Patch is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Merz North America, Inc.. The 510(k) number is K172689.
When did DESCRIBE PFD Patch receive FDA 510(k) clearance?
DESCRIBE PFD Patch received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172689.
Who is the listed applicant for DESCRIBE PFD Patch?
The FDA 510(k) record lists Merz North America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DESCRIBE PFD Patch?
The FDA product code for DESCRIBE PFD Patch is PKO.
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官方来源
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