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FDA 510(k)

GIZMO

K-Number: K023574 · 2002-12-04

ApplicantFreedom Designs, Inc.
Decision Date2002-12-04
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GIZMO is the device name listed in this FDA 510(k) record. The listed applicant is Freedom Designs, Inc.. It received FDA 510(k) clearance on 2002-12-04 under 510(k) number K023574. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIZMO?

GIZMO is a medical device that received FDA 510(k) clearance on 2002-12-04. The listed applicant is Freedom Designs, Inc.. The 510(k) number is K023574.

When did GIZMO receive FDA 510(k) clearance?

GIZMO received FDA 510(k) clearance on 2002-12-04, under 510(k) number K023574.

Who is the listed applicant for GIZMO?

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

What is the FDA product code for GIZMO?

The FDA product code for GIZMO is IOR.

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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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