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FDA 510(k)

SCAN LT40 (40 CHANNELS)

K-Number: K001564 · 2000-11-24

ApplicantNeuro Scan Labs
Decision Date2000-11-24
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SCAN LT40 (40 CHANNELS) is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Scan Labs. It received FDA 510(k) clearance on 2000-11-24 under 510(k) number K001564. 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 SCAN LT40 (40 CHANNELS)?

SCAN LT40 (40 CHANNELS) is a medical device that received FDA 510(k) clearance on 2000-11-24. The listed applicant is Neuro Scan Labs. The 510(k) number is K001564.

When did SCAN LT40 (40 CHANNELS) receive FDA 510(k) clearance?

SCAN LT40 (40 CHANNELS) received FDA 510(k) clearance on 2000-11-24, under 510(k) number K001564.

Who is the listed applicant for SCAN LT40 (40 CHANNELS)?

The FDA 510(k) record lists Neuro Scan Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCAN LT40 (40 CHANNELS)?

The FDA product code for SCAN LT40 (40 CHANNELS) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Neuro Scan Labs 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.

K001562NEURO SCAN MEDICAL SYSTEMS A4000K001324SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)

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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