reSET-O
K号: K173681 · 2018-12-10
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决定日期2018-12-10
产品代码PWE
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
reSET-O is the device name listed in this FDA 510(k) record. The listed applicant is Pear Therapeutics, Inc.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K173681. The device is classified under product code PWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the reSET-O?
reSET-O is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Pear Therapeutics, Inc.. The 510(k) number is K173681.
When did reSET-O receive FDA 510(k) clearance?
reSET-O received FDA 510(k) clearance on 2018-12-10, under 510(k) number K173681.
Who is the listed applicant for reSET-O?
The FDA 510(k) record lists Pear Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for reSET-O?
The FDA product code for reSET-O is PWE.
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列明Pear Therapeutics, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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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