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FDA 510(k)

NAVIGUS NEXDRIVE, MODEL MI-3000

K-Number: K043091 · 2005-02-07

ApplicantImage-Guided Neurologics, Inc.
Decision Date2005-02-07
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVIGUS NEXDRIVE, MODEL MI-3000 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 2005-02-07 under 510(k) number K043091. 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 NEXDRIVE, MODEL MI-3000?

NAVIGUS NEXDRIVE, MODEL MI-3000 is a medical device that received FDA 510(k) clearance on 2005-02-07. The listed applicant is Image-Guided Neurologics, Inc.. The 510(k) number is K043091.

When did NAVIGUS NEXDRIVE, MODEL MI-3000 receive FDA 510(k) clearance?

NAVIGUS NEXDRIVE, MODEL MI-3000 received FDA 510(k) clearance on 2005-02-07, under 510(k) number K043091.

Who is the listed applicant for NAVIGUS NEXDRIVE, MODEL MI-3000?

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 NEXDRIVE, MODEL MI-3000?

The FDA product code for NAVIGUS NEXDRIVE, MODEL MI-3000 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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