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FDA 510(k)

Pascall Sensor Unit (PSU1)

K-Number: K254213 · 2026-08-19

ApplicantPascall Systems, Inc.
Decision Date2026-08-19
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Pascall Sensor Unit (PSU1) 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 2026-08-19 under 510(k) number K254213. 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 Pascall Sensor Unit (PSU1)?

Pascall Sensor Unit (PSU1) is a medical device that received FDA 510(k) clearance on 2026-08-19. The listed applicant is Pascall Systems, Inc.. The 510(k) number is K254213.

When did Pascall Sensor Unit (PSU1) receive FDA 510(k) clearance?

Pascall Sensor Unit (PSU1) received FDA 510(k) clearance on 2026-08-19, under 510(k) number K254213.

Who is the listed applicant for Pascall Sensor Unit (PSU1)?

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 Pascall Sensor Unit (PSU1)?

The FDA product code for Pascall Sensor Unit (PSU1) is OLT.

Other records listing Pascall 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.

K213299Wireless EEG System

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.K213299Wireless EEG SystemPascall Systems, 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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