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FDA 510(k)

INTEGRATED INNOVA - S5I SYSTEM OPTION

K-Number: K111209 · 2011-07-26

ApplicantGE Healthcare
Decision Date2011-07-26
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTEGRATED INNOVA - S5I SYSTEM OPTION is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2011-07-26 under 510(k) number K111209. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRATED INNOVA - S5I SYSTEM OPTION?

INTEGRATED INNOVA - S5I SYSTEM OPTION is a medical device that received FDA 510(k) clearance on 2011-07-26. The listed applicant is GE Healthcare. The 510(k) number is K111209.

When did INTEGRATED INNOVA - S5I SYSTEM OPTION receive FDA 510(k) clearance?

INTEGRATED INNOVA - S5I SYSTEM OPTION received FDA 510(k) clearance on 2011-07-26, under 510(k) number K111209.

Who is the listed applicant for INTEGRATED INNOVA - S5I SYSTEM OPTION?

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 INTEGRATED INNOVA - S5I SYSTEM OPTION?

The FDA product code for INTEGRATED INNOVA - S5I SYSTEM OPTION is IZI.

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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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