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FDA 510(k)

INNOVA AND INNOVA 2000 S

K-Number: K022322 · 2002-10-08

ApplicantGe Medical Systems, Inc.
Decision Date2002-10-08
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INNOVA AND INNOVA 2000 S 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 2002-10-08 under 510(k) number K022322. 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 AND INNOVA 2000 S?

INNOVA AND INNOVA 2000 S is a medical device that received FDA 510(k) clearance on 2002-10-08. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K022322.

When did INNOVA AND INNOVA 2000 S receive FDA 510(k) clearance?

INNOVA AND INNOVA 2000 S received FDA 510(k) clearance on 2002-10-08, under 510(k) number K022322.

Who is the listed applicant for INNOVA AND INNOVA 2000 S?

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 AND INNOVA 2000 S?

The FDA product code for INNOVA AND INNOVA 2000 S 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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