BT-1000
K号: K232991 · 2024-08-28
广告
决定日期2024-08-28
产品代码QGL
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
BT-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Bistos Co., Ltd.. It received FDA 510(k) clearance on 2024-08-28 under 510(k) number K232991. The device is classified under product code QGL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BT-1000?
BT-1000 is a medical device that received FDA 510(k) clearance on 2024-08-28. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K232991.
When did BT-1000 receive FDA 510(k) clearance?
BT-1000 received FDA 510(k) clearance on 2024-08-28, under 510(k) number K232991.
Who is the listed applicant for BT-1000?
The FDA 510(k) record lists Bistos Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BT-1000?
The FDA product code for BT-1000 is QGL.
列明Bistos Co., Ltd.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：QGL）
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。
广告