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FDA 510(k)

NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1

K-Number: K010669 · 2001-06-04

ApplicantThuris Corp.
Decision Date2001-06-04
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 is the device name listed in this FDA 510(k) record. The listed applicant is Thuris Corp.. It received FDA 510(k) clearance on 2001-06-04 under 510(k) number K010669. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1?

NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 is a medical device that received FDA 510(k) clearance on 2001-06-04. The listed applicant is Thuris Corp.. The 510(k) number is K010669.

When did NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 receive FDA 510(k) clearance?

NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 received FDA 510(k) clearance on 2001-06-04, under 510(k) number K010669.

Who is the listed applicant for NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1?

The FDA 510(k) record lists Thuris Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1?

The FDA product code for NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 is GWQ.

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Related Devices (Code: GWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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