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FDA 510(k)

NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000

K-Number: K024201 · 2003-03-12

ApplicantImage-Guided Neurologics, Inc.
Decision Date2003-03-12
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 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 2003-03-12 under 510(k) number K024201. 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 FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000?

NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 is a medical device that received FDA 510(k) clearance on 2003-03-12. The listed applicant is Image-Guided Neurologics, Inc.. The 510(k) number is K024201.

When did NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 receive FDA 510(k) clearance?

NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 received FDA 510(k) clearance on 2003-03-12, under 510(k) number K024201.

Who is the listed applicant for NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000?

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 FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000?

The FDA product code for NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 is HAW.

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Other records listing Image-Guided Neurologics, 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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