微铃
K号: K221356 · 2023-02-02
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申请人Wee Medical
决定日期2023-02-02
产品代码HFX
咨询委员会OB
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决定实质等同
器械摘要
Wee Bell is the device name listed in this FDA 510(k) record. The listed applicant is Wee Medical. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K221356. The device is classified under product code HFX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Wee Bell?
Wee Bell is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Wee Medical. The 510(k) number is K221356.
When did Wee Bell receive FDA 510(k) clearance?
Wee Bell received FDA 510(k) clearance on 2023-02-02, under 510(k) number K221356.
Who is the listed applicant for Wee Bell?
The FDA 510(k) record lists Wee Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Wee Bell?
The FDA product code for Wee Bell is HFX.
相关器械（代码：HFX）
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官方来源
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