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FDA 510(k)

Voluson P6 and Voluson P8

K-Number: K180535 · 2018-03-29

ApplicantGE Healthcare
Decision Date2018-03-29
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Voluson P6 and Voluson P8 is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2018-03-29 under approval number K180535. 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 P6 and Voluson P8?

Voluson P6 and Voluson P8 is a medical device that received FDA 510(k) clearance on 2018-03-29. It is manufactured by GE Healthcare. The 510(k) number is K180535.

When was Voluson P6 and Voluson P8 approved by the FDA?

Voluson P6 and Voluson P8 received FDA 510(k) clearance on 2018-03-29, under approval number K180535.

What company makes Voluson P6 and Voluson P8?

Voluson P6 and Voluson P8 is manufactured by GE Healthcare.

What is the FDA product code for Voluson P6 and Voluson P8?

The FDA product code for Voluson P6 and Voluson P8 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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