Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NEUROMATIC 2000

K-Number: K821237 · 1982-05-21

ApplicantDisa Electronics
Decision Date1982-05-21
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEUROMATIC 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Disa Electronics. It received FDA 510(k) clearance on 1982-05-21 under 510(k) number K821237. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROMATIC 2000?

NEUROMATIC 2000 is a medical device that received FDA 510(k) clearance on 1982-05-21. The listed applicant is Disa Electronics. The 510(k) number is K821237.

When did NEUROMATIC 2000 receive FDA 510(k) clearance?

NEUROMATIC 2000 received FDA 510(k) clearance on 1982-05-21, under 510(k) number K821237.

Who is the listed applicant for NEUROMATIC 2000?

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

What is the FDA product code for NEUROMATIC 2000?

The FDA product code for NEUROMATIC 2000 is IKN.

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 Disa Electronics 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.

K820144DISA WATER CYSTOMETER

Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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.

↑