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FDA 510(k)

XLTEK NEUROPATH, MODEL PK1070

K-Number: K053058 · 2006-02-07

ApplicantExcel Tech. , Ltd.
Decision Date2006-02-07
Product CodeJXE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XLTEK NEUROPATH, MODEL PK1070 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 2006-02-07 under 510(k) number K053058. The device is classified under product code JXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XLTEK NEUROPATH, MODEL PK1070?

XLTEK NEUROPATH, MODEL PK1070 is a medical device that received FDA 510(k) clearance on 2006-02-07. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K053058.

When did XLTEK NEUROPATH, MODEL PK1070 receive FDA 510(k) clearance?

XLTEK NEUROPATH, MODEL PK1070 received FDA 510(k) clearance on 2006-02-07, under 510(k) number K053058.

Who is the listed applicant for XLTEK NEUROPATH, MODEL PK1070?

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 NEUROPATH, MODEL PK1070?

The FDA product code for XLTEK NEUROPATH, MODEL PK1070 is JXE.

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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 PK1072K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059K052111XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382K042223XLTEK CONNEX IP HEADBOX, MODEL 1054

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Related Devices (Code: JXE)

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.

K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto,K190536Mediracer NCSMediracer OYK070109NEUROMETRIX ADVANCENeurometrix, Inc.K060584NC-STATNeurometrix, Inc.K052904VIRTUAL MEDICAL SYSTEMS MODEL VT3000Scientific Imaging, Inc.K041320MODIFICATION TO NC-STATNeurometrix, Inc.

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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