Mercy babyTAPE
K号: K191174 · 2019-10-10
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决定日期2019-10-10
产品代码PIR
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
Mercy babyTAPE is the device name listed in this FDA 510(k) record. The listed applicant is Children'S Mercy Hospital. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K191174. The device is classified under product code PIR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Mercy babyTAPE?
Mercy babyTAPE is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Children'S Mercy Hospital. The 510(k) number is K191174.
When did Mercy babyTAPE receive FDA 510(k) clearance?
Mercy babyTAPE received FDA 510(k) clearance on 2019-10-10, under 510(k) number K191174.
Who is the listed applicant for Mercy babyTAPE?
The FDA 510(k) record lists Children'S Mercy Hospital as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mercy babyTAPE?
The FDA product code for Mercy babyTAPE is PIR.
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