PATI (防止舌部受伤)
K号: K221469 · 2023-02-22
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决定日期2023-02-22
产品代码JXL
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
PATI (Protector Against Tongue Injury) is the device name listed in this FDA 510(k) record. The listed applicant is Neurovice, LLC. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K221469. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PATI (Protector Against Tongue Injury)?
PATI (Protector Against Tongue Injury) is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Neurovice, LLC. The 510(k) number is K221469.
When did PATI (Protector Against Tongue Injury) receive FDA 510(k) clearance?
PATI (Protector Against Tongue Injury) received FDA 510(k) clearance on 2023-02-22, under 510(k) number K221469.
Who is the listed applicant for PATI (Protector Against Tongue Injury)?
The FDA 510(k) record lists Neurovice, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PATI (Protector Against Tongue Injury)?
The FDA product code for PATI (Protector Against Tongue Injury) is JXL.
相关临床试验
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相关器械（代码：JXL）
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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