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FDA 510(k)

NEUROTRAC II

K-Number: K914571 · 1992-01-30

ApplicantMoberg Medical, Inc.
Decision Date1992-01-30
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROTRAC II is the device name listed in this FDA 510(k) record. The listed applicant is Moberg Medical, Inc.. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K914571. 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 NEUROTRAC II?

NEUROTRAC II is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Moberg Medical, Inc.. The 510(k) number is K914571.

When did NEUROTRAC II receive FDA 510(k) clearance?

NEUROTRAC II received FDA 510(k) clearance on 1992-01-30, under 510(k) number K914571.

Who is the listed applicant for NEUROTRAC II?

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

What is the FDA product code for NEUROTRAC II?

The FDA product code for NEUROTRAC II 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.

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 Moberg Medical, 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.

K960170ELECTROENCEPHALOGRAPH (EEG)

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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