Back 3 COLOR
K号: K214090 · 2022-11-01
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决定日期2022-11-01
产品代码PBX
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
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器械摘要
Back 3 COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Swims America Corp. It received FDA 510(k) clearance on 2022-11-01 under 510(k) number K214090. 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 Back 3 COLOR?
Back 3 COLOR is a medical device that received FDA 510(k) clearance on 2022-11-01. The listed applicant is Swims America Corp. The 510(k) number is K214090.
When did Back 3 COLOR receive FDA 510(k) clearance?
Back 3 COLOR received FDA 510(k) clearance on 2022-11-01, under 510(k) number K214090.
Who is the listed applicant for Back 3 COLOR?
The FDA 510(k) record lists Swims America Corp as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Back 3 COLOR?
The FDA product code for Back 3 COLOR is PBX.
相关临床试验
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列明Swims America Corp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。
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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