FDA 510(k)

Spectra 毛绒

K号: K191208 · 2019-10-11

决定日期2019-10-11

产品代码HGX

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决定实质等同

器械摘要

Spectra Cashmere is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co.. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K191208. 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 Cashmere?

Spectra Cashmere is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Uzinmedicare Co.. The 510(k) number is K191208.

When did Spectra Cashmere receive FDA 510(k) clearance?

Spectra Cashmere received FDA 510(k) clearance on 2019-10-11, under 510(k) number K191208.

Who is the listed applicant for Spectra Cashmere?

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 Cashmere?

The FDA product code for Spectra Cashmere is HGX.

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。

K210124Synergy Gold (SG) 便携式（型号 MM011450 和 MM011460）K191109Spectra Q K181784Spectra S3 Plus K150476Spectra S1Plus and Spectra S2 Plus

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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