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FDA 510(k)

Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR

K-Number: K181403 · 2018-11-02

ApplicantGE Healthcare
Decision Date2018-11-02
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2018-11-02 under approval number K181403. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR?

Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by GE Healthcare. The 510(k) number is K181403.

When was Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR approved by the FDA?

Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR received FDA 510(k) clearance on 2018-11-02, under approval number K181403.

What company makes Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR?

Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR is manufactured by GE Healthcare.

What is the FDA product code for Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR?

The FDA product code for Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR is OWB.

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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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