BTL-094
K号: K221865 · 2023-04-14
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决定日期2023-04-14
产品代码ISA
咨询委员会PM
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决定实质等同
器械摘要
BTL-094 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 2023-04-14 under 510(k) number K221865. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BTL-094?
BTL-094 is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is BTL Industries, Inc.. The 510(k) number is K221865.
When did BTL-094 receive FDA 510(k) clearance?
BTL-094 received FDA 510(k) clearance on 2023-04-14, under 510(k) number K221865.
Who is the listed applicant for BTL-094?
FDA 510(k)记录中列出了BTL Industries, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for BTL-094?
The FDA product code for BTL-094 is ISA.
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：ISA）
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。
K243488VMAT PROTermosaludK240358ShockPhysio 移动式（型号 SW3200 Basic）Shenzhen Dongdixin Technology Co., Ltd.K210166Omnispec ED1000Medispec, Ltd.K213120OW100S (型号 OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave TrtK220538DolorClast RadialE.M.S Electro Medical Systems S.AK210451OrthoGold 100Tissue Regeneration Technologies, LLC
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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