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FDA 510(k)

PEDIGUARD NERVE DETECTOR SYSTEM

K-Number: K030526 · 2004-12-29

ApplicantSpine Vision, Inc.
Decision Date2004-12-29
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PEDIGUARD NERVE DETECTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine Vision, Inc.. It received FDA 510(k) clearance on 2004-12-29 under 510(k) number K030526. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIGUARD NERVE DETECTOR SYSTEM?

PEDIGUARD NERVE DETECTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-29. The listed applicant is Spine Vision, Inc.. The 510(k) number is K030526.

When did PEDIGUARD NERVE DETECTOR SYSTEM receive FDA 510(k) clearance?

PEDIGUARD NERVE DETECTOR SYSTEM received FDA 510(k) clearance on 2004-12-29, under 510(k) number K030526.

Who is the listed applicant for PEDIGUARD NERVE DETECTOR SYSTEM?

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

What is the FDA product code for PEDIGUARD NERVE DETECTOR SYSTEM?

The FDA product code for PEDIGUARD NERVE DETECTOR SYSTEM is GWF.

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Other records listing Spine Vision, Inc. as applicant

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Related Devices (Code: GWF)

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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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