比力-胡特
K号: K190899 · 2019-09-05
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决定日期2019-09-05
产品代码LBI
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
bili-hut is the device name listed in this FDA 510(k) record. The listed applicant is Little Sparrows Technologies, Inc.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) number K190899. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the bili-hut?
bili-hut is a medical device that received FDA 510(k) clearance on 2019-09-05. The listed applicant is Little Sparrows Technologies, Inc.. The 510(k) number is K190899.
When did bili-hut receive FDA 510(k) clearance?
bili-hut received FDA 510(k) clearance on 2019-09-05, under 510(k) number K190899.
Who is the listed applicant for bili-hut?
The FDA 510(k) record lists Little Sparrows Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for bili-hut?
The FDA product code for bili-hut is LBI.
相关器械（代码：LBI）
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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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