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FDA 510(k)

VOLUSON S6, VOLUSON S8

K-Number: K120741 · 2012-04-27

ApplicantGE Healthcare
Decision Date2012-04-27
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOLUSON S6, VOLUSON S8 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2012-04-27 under 510(k) number K120741. 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 S6, VOLUSON S8?

VOLUSON S6, VOLUSON S8 is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is GE Healthcare. The 510(k) number is K120741.

When did VOLUSON S6, VOLUSON S8 receive FDA 510(k) clearance?

VOLUSON S6, VOLUSON S8 received FDA 510(k) clearance on 2012-04-27, under 510(k) number K120741.

Who is the listed applicant for VOLUSON S6, VOLUSON S8?

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 S6, VOLUSON S8?

The FDA product code for VOLUSON S6, VOLUSON S8 is IYN.

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Related Devices (Code: 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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