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FDA 510(k)

Voluson E6, Voluson E8, Voluson E10

K-Number: K192159 · 2019-08-29

ApplicantGE Healthcare
Decision Date2019-08-29
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Voluson E6, Voluson E8, Voluson E10 is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2019-08-29 under approval number K192159. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Voluson E6, Voluson E8, Voluson E10?

Voluson E6, Voluson E8, Voluson E10 is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by GE Healthcare. The 510(k) number is K192159.

When was Voluson E6, Voluson E8, Voluson E10 approved by the FDA?

Voluson E6, Voluson E8, Voluson E10 received FDA 510(k) clearance on 2019-08-29, under approval number K192159.

What company makes Voluson E6, Voluson E8, Voluson E10?

Voluson E6, Voluson E8, Voluson E10 is manufactured by GE Healthcare.

What is the FDA product code for Voluson E6, Voluson E8, Voluson E10?

The FDA product code for Voluson E6, Voluson E8, Voluson E10 is IYN.

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Official Source

View on FDA Database →

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

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