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FDA 510(k)

EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION

K-Number: K032741 · 2003-12-16

ApplicantAxon Systems, Inc.
Decision Date2003-12-16
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Axon Systems, Inc.. It received FDA 510(k) clearance on 2003-12-16 under 510(k) number K032741. 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 EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION?

EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION is a medical device that received FDA 510(k) clearance on 2003-12-16. The listed applicant is Axon Systems, Inc.. The 510(k) number is K032741.

When did EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION receive FDA 510(k) clearance?

EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION received FDA 510(k) clearance on 2003-12-16, under 510(k) number K032741.

Who is the listed applicant for EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION?

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

What is the FDA product code for EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION?

The FDA product code for EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION is 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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