FDA 510(k)

VIVA combo RF System

K-Number: K183538 · 2019-01-17

Decision Date2019-01-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VIVA combo RF System is a medical device manufactured by Starmed Co., Ltd.. It received FDA 510(k) clearance on 2019-01-17 under approval number K183538. 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 is a medical device that received FDA 510(k) clearance on 2019-01-17. It is manufactured by Starmed Co., Ltd.. The 510(k) number is K183538.

When was VIVA combo RF System approved by the FDA?

VIVA combo RF System received FDA 510(k) clearance on 2019-01-17, under approval number K183538.

What company makes 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?

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

Other Devices by Starmed Co., Ltd.

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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.