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FDA 510(k)

ACTITRAC

K-Number: K992410 · 1999-10-15

ApplicantIndividual Monitoring Systems, Inc.
Decision Date1999-10-15
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACTITRAC is the device name listed in this FDA 510(k) record. The listed applicant is Individual Monitoring Systems, Inc.. It received FDA 510(k) clearance on 1999-10-15 under 510(k) number K992410. 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 ACTITRAC?

ACTITRAC is a medical device that received FDA 510(k) clearance on 1999-10-15. The listed applicant is Individual Monitoring Systems, Inc.. The 510(k) number is K992410.

When did ACTITRAC receive FDA 510(k) clearance?

ACTITRAC received FDA 510(k) clearance on 1999-10-15, under 510(k) number K992410.

Who is the listed applicant for ACTITRAC?

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

What is the FDA product code for ACTITRAC?

The FDA product code for ACTITRAC 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 Individual Monitoring 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.

K010997PAM-RL

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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