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FDA 510(k)

Wireless EEG System

K-Number: K213299 · 2022-05-11

ApplicantPascall Systems, Inc.
Decision Date2022-05-11
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Wireless EEG System is the device name listed in this FDA 510(k) record. The listed applicant is Pascall Systems, Inc.. It received FDA 510(k) clearance on 2022-05-11 under 510(k) number K213299. 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 Wireless EEG System?

Wireless EEG System is a medical device that received FDA 510(k) clearance on 2022-05-11. The listed applicant is Pascall Systems, Inc.. The 510(k) number is K213299.

When did Wireless EEG System receive FDA 510(k) clearance?

Wireless EEG System received FDA 510(k) clearance on 2022-05-11, under 510(k) number K213299.

Who is the listed applicant for Wireless EEG System?

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

What is the FDA product code for Wireless EEG System?

The FDA product code for Wireless EEG System is OLT.

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.

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.K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft , Ltd.K191322E-EEGX, N-EEGXGE Healthcare Finland Oy

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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