BTL-703-2
K号: K200382 · 2021-01-06
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申请人Btl
决定日期2021-01-06
产品代码NGX
咨询委员会PM
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决定实质等同
器械摘要
BTL-703-2 is the device name listed in this FDA 510(k) record. The listed applicant is Btl. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K200382. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BTL-703-2?
BTL-703-2 is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Btl. The 510(k) number is K200382.
When did BTL-703-2 receive FDA 510(k) clearance?
BTL-703-2 received FDA 510(k) clearance on 2021-01-06, under 510(k) number K200382.
Who is the listed applicant for BTL-703-2?
The FDA 510(k) record lists Btl as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BTL-703-2?
The FDA product code for BTL-703-2 is NGX.
列明Btl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。
相关器械（代码：NGX）
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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