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FDA 510(k)

UNIQUE AMBULATORY EEG

K-Number: K010697 · 2001-06-06

ApplicantAxon Systems, Inc.
Decision Date2001-06-06
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

UNIQUE AMBULATORY EEG is the device name listed in this FDA 510(k) record. The listed applicant is Axon Systems, Inc.. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K010697. 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 UNIQUE AMBULATORY EEG?

UNIQUE AMBULATORY EEG is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Axon Systems, Inc.. The 510(k) number is K010697.

When did UNIQUE AMBULATORY EEG receive FDA 510(k) clearance?

UNIQUE AMBULATORY EEG received FDA 510(k) clearance on 2001-06-06, under 510(k) number K010697.

Who is the listed applicant for UNIQUE AMBULATORY EEG?

The FDA 510(k) record lists Axon Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIQUE AMBULATORY EEG?

The FDA product code for UNIQUE AMBULATORY EEG is GWQ.

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Other records listing Axon Systems, Inc. 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.

K090838STIMULUS/DISSECTION INSTRUMENTSK062996DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBESK062198SUNSPOTS PRE-GELLED SURFACE ELECTRODESK061639ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMONK061113ORTHOMONK050798ECLIPSE NEUROLOGICAL WORKSTATION

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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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