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FDA 510(k)

SELF ADHERING NAVIGUS GUIDE

K-Number: K001192 · 2000-06-07

ApplicantImage-Guided Neurologics, Inc.
Decision Date2000-06-07
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SELF ADHERING NAVIGUS GUIDE 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 2000-06-07 under 510(k) number K001192. 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 SELF ADHERING NAVIGUS GUIDE?

SELF ADHERING NAVIGUS GUIDE is a medical device that received FDA 510(k) clearance on 2000-06-07. The listed applicant is Image-Guided Neurologics, Inc.. The 510(k) number is K001192.

When did SELF ADHERING NAVIGUS GUIDE receive FDA 510(k) clearance?

SELF ADHERING NAVIGUS GUIDE received FDA 510(k) clearance on 2000-06-07, under 510(k) number K001192.

Who is the listed applicant for SELF ADHERING NAVIGUS GUIDE?

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 SELF ADHERING NAVIGUS GUIDE?

The FDA product code for SELF ADHERING NAVIGUS GUIDE 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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