Spectra S1Plus and Spectra S2 Plus
K号: K150476 · 2016-04-15
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决定日期2016-04-15
产品代码HGX
咨询委员会OB
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决定实质等同
器械摘要
Spectra S1Plus and Spectra S2 Plus is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K150476. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Spectra S1Plus and Spectra S2 Plus?
Spectra S1Plus and Spectra S2 Plus is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Uzinmedicare Co.. The 510(k) number is K150476.
When did Spectra S1Plus and Spectra S2 Plus receive FDA 510(k) clearance?
Spectra S1Plus and Spectra S2 Plus received FDA 510(k) clearance on 2016-04-15, under 510(k) number K150476.
Who is the listed applicant for Spectra S1Plus and Spectra S2 Plus?
The FDA 510(k) record lists Uzinmedicare Co. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Spectra S1Plus and Spectra S2 Plus?
The FDA product code for Spectra S1Plus and Spectra S2 Plus is HGX.
相关临床试验
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列明Uzinmedicare Co.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：HGX）
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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