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FDA 510(k)

INNOVA 3100

K-Number: K031637 · 2003-08-22

ApplicantGE Medical Systems
Decision Date2003-08-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INNOVA 3100 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2003-08-22 under 510(k) number K031637. 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 3100?

INNOVA 3100 is a medical device that received FDA 510(k) clearance on 2003-08-22. The listed applicant is GE Medical Systems. The 510(k) number is K031637.

When did INNOVA 3100 receive FDA 510(k) clearance?

INNOVA 3100 received FDA 510(k) clearance on 2003-08-22, under 510(k) number K031637.

Who is the listed applicant for INNOVA 3100?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVA 3100?

The FDA product code for INNOVA 3100 is OWB.

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Other records listing GE Medical Systems as applicant

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Related Devices (Code: 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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