FDA 510(k)

VIVA组合射频系统（VIVA组合射频系统）

K号: K234140 · 2024-01-30

决定日期2024-01-30

产品代码GEI

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决定实质等同

器械摘要

VIVA combo RF System (VIVA combo RF System) is the device name listed in this FDA 510(k) record. The listed applicant is Starmed Co., Ltd.. It received FDA 510(k) clearance on 2024-01-30 under 510(k) number K234140. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VIVA combo RF System (VIVA combo RF System)?

VIVA combo RF System (VIVA combo RF System) is a medical device that received FDA 510(k) clearance on 2024-01-30. The listed applicant is Starmed Co., Ltd.. The 510(k) number is K234140.

When did VIVA combo RF System (VIVA combo RF System) receive FDA 510(k) clearance?

VIVA combo RF System (VIVA combo RF System) received FDA 510(k) clearance on 2024-01-30, under 510(k) number K234140.

Who is the listed applicant for VIVA combo RF System (VIVA combo RF System)?

The FDA 510(k) record lists Starmed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIVA combo RF System (VIVA combo RF System)?

The FDA product code for VIVA combo RF System (VIVA combo RF System) is GEI.

列明Starmed Co., Ltd.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。

K252833VIVA组合射频系统 K251566TS-RF Generator (STS10)K233113ELRA 电极（7-2B11S，7-2B11L，7-2B22S，7-2B22L，7-4B18S，7-4B18L，7-4B33S，7-4B33L）K222997VVR发生器系统 K203795Star RF 电极，VIVA RF 电极 K181758ELRA 电极

查看所有 11 个设备 →

相关器械（代码：GEI）

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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