TR-100
K号: K161551 · 2016-09-13
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器械摘要
TR-100 is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2016-09-13 under 510(k) number K161551. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TR-100?
TR-100 is a medical device that received FDA 510(k) clearance on 2016-09-13. The listed applicant is BTL Industries, Inc.. The 510(k) number is K161551.
When did TR-100 receive FDA 510(k) clearance?
TR-100 received FDA 510(k) clearance on 2016-09-13, under 510(k) number K161551.
Who is the listed applicant for TR-100?
The FDA 510(k) record lists BTL Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TR-100?
The FDA product code for TR-100 is PBX.
列明BTL Industries, 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。
相关器械（代码：PBX）
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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