Uresta®
K号: K233548 · 2024-04-03
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决定日期2024-04-03
产品代码HHW
咨询委员会OB
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决定实质等同
器械摘要
Uresta® is the device name listed in this FDA 510(k) record. The listed applicant is Resilia, Inc.. It received FDA 510(k) clearance on 2024-04-03 under 510(k) number K233548. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Uresta®?
Uresta® is a medical device that received FDA 510(k) clearance on 2024-04-03. The listed applicant is Resilia, Inc.. The 510(k) number is K233548.
When did Uresta® receive FDA 510(k) clearance?
Uresta® received FDA 510(k) clearance on 2024-04-03, under 510(k) number K233548.
Who is the listed applicant for Uresta®?
The FDA 510(k) record lists Resilia, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Uresta®?
The FDA product code for Uresta® is HHW.
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相关器械（代码：HHW）
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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