FDA 510(k)

VIVA combo RF System (VIVA combo RF System)

K-Number: K234140 · 2024-01-30

Decision Date2024-01-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Starmed Co., Ltd.. The 510(k) number is K234140.

When was VIVA combo RF System (VIVA combo RF System) approved by the FDA?

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

What company makes VIVA combo RF System (VIVA combo RF System)?

VIVA combo RF System (VIVA combo RF System) is manufactured by Starmed Co., Ltd..

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.