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FDA 510(k)

VIGILANT EEG MONITOR MODEL VIGILANT 2.0

K-Number: K101386 · 2010-07-30

ApplicantInfinite Biomedical Technologies, LLC
Decision Date2010-07-30
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VIGILANT EEG MONITOR MODEL VIGILANT 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Infinite Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2010-07-30 under 510(k) number K101386. 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 VIGILANT EEG MONITOR MODEL VIGILANT 2.0?

VIGILANT EEG MONITOR MODEL VIGILANT 2.0 is a medical device that received FDA 510(k) clearance on 2010-07-30. The listed applicant is Infinite Biomedical Technologies, LLC. The 510(k) number is K101386.

When did VIGILANT EEG MONITOR MODEL VIGILANT 2.0 receive FDA 510(k) clearance?

VIGILANT EEG MONITOR MODEL VIGILANT 2.0 received FDA 510(k) clearance on 2010-07-30, under 510(k) number K101386.

Who is the listed applicant for VIGILANT EEG MONITOR MODEL VIGILANT 2.0?

The FDA 510(k) record lists Infinite Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIGILANT EEG MONITOR MODEL VIGILANT 2.0?

The FDA product code for VIGILANT EEG MONITOR MODEL VIGILANT 2.0 is GWQ.

Related Clinical Trials

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.

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Other records listing Infinite Biomedical Technologies, LLC 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.

K240884Glide (91000-GL-X)K182112Sense System with IBT ElectrodesK173571Element System with IBT ElectrodesK091963VIGILANT EEG MONITOR, VIGILANT 2.0

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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