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FDA 510(k)

XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP

K-Number: K010087 · 2001-03-19

ApplicantExcel Tech. , Ltd.
Decision Date2001-03-19
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP is the device name listed in this FDA 510(k) record. The listed applicant is Excel Tech. , Ltd.. It received FDA 510(k) clearance on 2001-03-19 under 510(k) number K010087. 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 REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP?

XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP is a medical device that received FDA 510(k) clearance on 2001-03-19. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K010087.

When did XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP receive FDA 510(k) clearance?

XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP received FDA 510(k) clearance on 2001-03-19, under 510(k) number K010087.

Who is the listed applicant for XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP?

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

What is the FDA product code for XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP?

The FDA product code for XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP is GWF.

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Other records listing Excel Tech. , Ltd. as applicant

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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

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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