导航器（FMNVG15）；导航器XL（FMNVX06）
K号: K240105 · 2024-08-29
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决定日期2024-08-29
产品代码ITI
咨询委员会PM
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Navigator (FMNVG15); Navigator XL (FMNVX06) is the device name listed in this FDA 510(k) record. The listed applicant is Forcemech International, LLC. It received FDA 510(k) clearance on 2024-08-29 under 510(k) number K240105. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Navigator (FMNVG15); Navigator XL (FMNVX06)?
Navigator (FMNVG15); Navigator XL (FMNVX06) is a medical device that received FDA 510(k) clearance on 2024-08-29. The listed applicant is Forcemech International, LLC. The 510(k) number is K240105.
When did Navigator (FMNVG15); Navigator XL (FMNVX06) receive FDA 510(k) clearance?
Navigator (FMNVG15); Navigator XL (FMNVX06) received FDA 510(k) clearance on 2024-08-29, under 510(k) number K240105.
Who is the listed applicant for Navigator (FMNVG15); Navigator XL (FMNVX06)?
The FDA 510(k) record lists Forcemech International, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Navigator (FMNVG15); Navigator XL (FMNVX06)?
The FDA product code for Navigator (FMNVG15); Navigator XL (FMNVX06) is ITI.
相关临床试验
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。
相关器械（代码：ITI）
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。
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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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