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FDA 510(k)

Viveve System 2.0

K-Number: K190422 · 2019-06-12

ApplicantViveve Medical
Decision Date2019-06-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Viveve System 2.0 is a medical device manufactured by Viveve Medical. It received FDA 510(k) clearance on 2019-06-12 under approval number K190422. 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 Viveve System 2.0?

Viveve System 2.0 is a medical device that received FDA 510(k) clearance on 2019-06-12. It is manufactured by Viveve Medical. The 510(k) number is K190422.

When was Viveve System 2.0 approved by the FDA?

Viveve System 2.0 received FDA 510(k) clearance on 2019-06-12, under approval number K190422.

What company makes Viveve System 2.0?

Viveve System 2.0 is manufactured by Viveve Medical.

What is the FDA product code for Viveve System 2.0?

The FDA product code for Viveve System 2.0 is GEI.

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Official Source

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