TeesuVac 乳腺活检设备型号 1
K号: K212079 · 2022-02-02
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申请人Teesuvac Aps
决定日期2022-02-02
产品代码KNW
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
TeesuVac Breast Biopsy Device Mark 1 is the device name listed in this FDA 510(k) record. The listed applicant is Teesuvac Aps. It received FDA 510(k) clearance on 2022-02-02 under 510(k) number K212079. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TeesuVac Breast Biopsy Device Mark 1?
TeesuVac Breast Biopsy Device Mark 1 is a medical device that received FDA 510(k) clearance on 2022-02-02. The listed applicant is Teesuvac Aps. The 510(k) number is K212079.
When did TeesuVac Breast Biopsy Device Mark 1 receive FDA 510(k) clearance?
TeesuVac Breast Biopsy Device Mark 1 received FDA 510(k) clearance on 2022-02-02, under 510(k) number K212079.
Who is the listed applicant for TeesuVac Breast Biopsy Device Mark 1?
The FDA 510(k) record lists Teesuvac Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TeesuVac Breast Biopsy Device Mark 1?
The FDA product code for TeesuVac Breast Biopsy Device Mark 1 is KNW.
相关临床试验
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：KNW）
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。
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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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