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FDA 510(k)

INNOVA 4100, INNOVA 3100

K-Number: K042053 · 2004-08-26

ApplicantGe Medical Systems, Inc.
Decision Date2004-08-26
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INNOVA 4100, INNOVA 3100 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-08-26 under 510(k) number K042053. 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 4100, INNOVA 3100?

INNOVA 4100, INNOVA 3100 is a medical device that received FDA 510(k) clearance on 2004-08-26. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K042053.

When did INNOVA 4100, INNOVA 3100 receive FDA 510(k) clearance?

INNOVA 4100, INNOVA 3100 received FDA 510(k) clearance on 2004-08-26, under 510(k) number K042053.

Who is the listed applicant for INNOVA 4100, INNOVA 3100?

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

What is the FDA product code for INNOVA 4100, INNOVA 3100?

The FDA product code for INNOVA 4100, INNOVA 3100 is OWB.

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Other records listing Ge Medical Systems, Inc. as applicant

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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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