BeShape One™ 设备
K号: K231628 · 2023-09-29
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决定日期2023-09-29
产品代码OHV
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。
决定实质等同
器械摘要
BeShape One™ Device is the device name listed in this FDA 510(k) record. The listed applicant is Beshape Technologies , Ltd.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K231628. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BeShape One™ Device?
BeShape One™ Device is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Beshape Technologies , Ltd.. The 510(k) number is K231628.
When did BeShape One™ Device receive FDA 510(k) clearance?
BeShape One™ Device received FDA 510(k) clearance on 2023-09-29, under 510(k) number K231628.
Who is the listed applicant for BeShape One™ Device?
The FDA 510(k) record lists Beshape Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BeShape One™ Device?
The FDA product code for BeShape One™ Device is OHV.
相关临床试验
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相关器械（代码：OHV）
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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