breastscape v1.0
K号: K211431 · 2021-08-02
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器械摘要
breastscape v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical. It received FDA 510(k) clearance on 2021-08-02 under 510(k) number K211431. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the breastscape v1.0?
breastscape v1.0 is a medical device that received FDA 510(k) clearance on 2021-08-02. The listed applicant is Olea Medical. The 510(k) number is K211431.
When did breastscape v1.0 receive FDA 510(k) clearance?
breastscape v1.0 received FDA 510(k) clearance on 2021-08-02, under 510(k) number K211431.
Who is the listed applicant for breastscape v1.0?
The FDA 510(k) record lists Olea Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for breastscape v1.0?
The FDA product code for breastscape v1.0 is QIH.
相关临床试验
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列明Olea Medical为申报人的其他记录
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相关器械（代码：QIH）
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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