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FDA 510(k)

XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248

K-Number: K040358 · 2004-08-06

ApplicantExcel Tech. , Ltd.
Decision Date2004-08-06
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 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 2004-08-06 under 510(k) number K040358. 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 PROTEKTOR STIMULATOR, MODELS 10247 & 10248?

XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 is a medical device that received FDA 510(k) clearance on 2004-08-06. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K040358.

When did XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 receive FDA 510(k) clearance?

XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 received FDA 510(k) clearance on 2004-08-06, under 510(k) number K040358.

Who is the listed applicant for XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248?

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 PROTEKTOR STIMULATOR, MODELS 10247 & 10248?

The FDA product code for XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 is GWF.

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Other records listing Excel Tech. , Ltd. 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.

K062549XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238K061269XLTEK CLEAN SIGNAL ADHESIVE ELECTRODESK053386XLTEK EMU40 EEG HEADBOX, MODEL PK1072K053058XLTEK NEUROPATH, MODEL PK1070K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059K052111XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382

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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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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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