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)

TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL

K-Number: K842886 · 1984-12-12

ApplicantTeca, Inc.
Decision Date1984-12-12
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1984-12-12 under 510(k) number K842886. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL?

TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL is a medical device that received FDA 510(k) clearance on 1984-12-12. The listed applicant is Teca, Inc.. The 510(k) number is K842886.

When did TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL receive FDA 510(k) clearance?

TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL received FDA 510(k) clearance on 1984-12-12, under 510(k) number K842886.

Who is the listed applicant for TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL?

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

What is the FDA product code for TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL?

The FDA product code for TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL is GWN.

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 Teca, 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.

K962283EEG ELECTRODESK903731SAPPHIRE SERIES 1P, 1L, 2L, AND 2MEK903004EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPHK896666P460, DG32 ELECTROENCEPHALOGRAPHK894889TECA NEUROMAPPER 386K894088TECA NEUROMAPPER 1620, BRAIN MAPPER

View all 29 devices →

Related Devices (Code: GWN)

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.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark ApsK242726Synapsys VHITInventis S.R.L.K223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular First

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.

↑