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FDA 510(k)

XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8

K-Number: K002969 · 2000-12-08

ApplicantXltek
Decision Date2000-12-08
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 is the device name listed in this FDA 510(k) record. The listed applicant is Xltek. It received FDA 510(k) clearance on 2000-12-08 under 510(k) number K002969. 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 XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8?

XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 is a medical device that received FDA 510(k) clearance on 2000-12-08. The listed applicant is Xltek. The 510(k) number is K002969.

When did XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 receive FDA 510(k) clearance?

XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 received FDA 510(k) clearance on 2000-12-08, under 510(k) number K002969.

Who is the listed applicant for XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8?

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

What is the FDA product code for XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8?

The FDA product code for XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 is GWF.

Related Clinical Trials

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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Other records listing Xltek as applicant

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.

K01414684 CHANNEL EEGK01414780 CHANNEL EEG

Related Devices (Code: GWF)

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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