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FDA 510(k)

MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT

K-Number: K012069 · 2001-08-01

ApplicantNeurotron Medical, Inc.
Decision Date2001-08-01
Product CodeJXE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Neurotron Medical, Inc.. It received FDA 510(k) clearance on 2001-08-01 under 510(k) number K012069. The device is classified under product code JXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT?

MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT is a medical device that received FDA 510(k) clearance on 2001-08-01. The listed applicant is Neurotron Medical, Inc.. The 510(k) number is K012069.

When did MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT receive FDA 510(k) clearance?

MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT received FDA 510(k) clearance on 2001-08-01, under 510(k) number K012069.

Who is the listed applicant for MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT?

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

What is the FDA product code for MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT?

The FDA product code for MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT is JXE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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