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FDA 510(k)

VIGILANT EEG MONITOR, VIGILANT 2.0

K-Number: K091963 · 2009-11-06

ApplicantInfinite Biomedical Technologies, LLC
Decision Date2009-11-06
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VIGILANT EEG MONITOR, 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 2009-11-06 under 510(k) number K091963. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIGILANT EEG MONITOR, VIGILANT 2.0?

VIGILANT EEG MONITOR, VIGILANT 2.0 is a medical device that received FDA 510(k) clearance on 2009-11-06. The listed applicant is Infinite Biomedical Technologies, LLC. The 510(k) number is K091963.

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

VIGILANT EEG MONITOR, VIGILANT 2.0 received FDA 510(k) clearance on 2009-11-06, under 510(k) number K091963.

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

The FDA product code for VIGILANT EEG MONITOR, VIGILANT 2.0 is OLT.

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 ElectrodesK101386VIGILANT EEG MONITOR MODEL VIGILANT 2.0

Related Devices (Code: OLT)

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.

K261712Ceribell EEG Analysis SoftwareCeribell, Inc.K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.K253767UB ERP SystemUniversal BrainK251881HippoMind (v1.0)HippoclinicK251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)Nihon Kohden CorporationK240593VEEGix EEG SystemNeuroServo, 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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