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FDA 510(k)

NEUROLINK IP, MODEL PK1113

K-Number: K081741 · 2008-10-31

ApplicantExcel-Tech Ltd. (Xltek)
Decision Date2008-10-31
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROLINK IP, MODEL PK1113 is the device name listed in this FDA 510(k) record. The listed applicant is Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2008-10-31 under 510(k) number K081741. 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 NEUROLINK IP, MODEL PK1113?

NEUROLINK IP, MODEL PK1113 is a medical device that received FDA 510(k) clearance on 2008-10-31. The listed applicant is Excel-Tech Ltd. (Xltek). The 510(k) number is K081741.

When did NEUROLINK IP, MODEL PK1113 receive FDA 510(k) clearance?

NEUROLINK IP, MODEL PK1113 received FDA 510(k) clearance on 2008-10-31, under 510(k) number K081741.

Who is the listed applicant for NEUROLINK IP, MODEL PK1113?

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

What is the FDA product code for NEUROLINK IP, MODEL PK1113?

The FDA product code for NEUROLINK IP, MODEL PK1113 is GWQ.

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Other records listing Excel-Tech Ltd. (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.

K123079OLYMPIC BRAINZ MONITORK120260ICTAK090277NATUS SLEEPWORKS, MODEL 104017K100126STELLATE GRIDVIEW

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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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