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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 the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2018-11-02 under 510(k) 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. The listed applicant is GE Healthcare. The 510(k) number is K181403.

When did Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR receive FDA 510(k) clearance?

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

Who is the listed applicant for Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR?

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 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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Related Devices (Code: OWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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