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FDA 510(k)

WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)

K-Number: K001103 · 2000-06-30

ApplicantExcel Tech. , Ltd.
Decision Date2000-06-30
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) 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 2000-06-30 under 510(k) number K001103. 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 WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)?

WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K001103.

When did WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) receive FDA 510(k) clearance?

WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) received FDA 510(k) clearance on 2000-06-30, under 510(k) number K001103.

Who is the listed applicant for WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)?

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 WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)?

The FDA product code for WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) is GWQ.

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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: 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

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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