FDA 510(k)

Voluson E6, Voluson E8, Voluson E10

K-Number: K162269 · 2016-10-03

Decision Date2016-10-03

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Voluson E6, Voluson E8, Voluson E10 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-10-03 under 510(k) number K162269. 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 2016-10-03. The listed applicant is GE Healthcare. The 510(k) number is K162269.

When did Voluson E6, Voluson E8, Voluson E10 receive FDA 510(k) clearance?

Voluson E6, Voluson E8, Voluson E10 received FDA 510(k) clearance on 2016-10-03, under 510(k) number K162269.

Who is the listed applicant for Voluson E6, Voluson E8, Voluson E10?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

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

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