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FDA 510(k)

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000

K-Number: K033619 · 2004-03-02

ApplicantImage-Guided Neurologics, Inc.
Decision Date2004-03-02
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 is the device name listed in this FDA 510(k) record. The listed applicant is Image-Guided Neurologics, Inc.. It received FDA 510(k) clearance on 2004-03-02 under 510(k) number K033619. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000?

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 is a medical device that received FDA 510(k) clearance on 2004-03-02. The listed applicant is Image-Guided Neurologics, Inc.. The 510(k) number is K033619.

When did NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 receive FDA 510(k) clearance?

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 received FDA 510(k) clearance on 2004-03-02, under 510(k) number K033619.

Who is the listed applicant for NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000?

The FDA 510(k) record lists Image-Guided Neurologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000?

The FDA product code for NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 is HAW.

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Other records listing Image-Guided Neurologics, Inc. as applicant

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Related Devices (Code: HAW)

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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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