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/MEDELEC AS-10 SENSOR

K-Number: K862906 · 1987-02-04

ApplicantTeca, Inc.
Decision Date1987-02-04
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TECA/MEDELEC AS-10 SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1987-02-04 under 510(k) number K862906. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECA/MEDELEC AS-10 SENSOR?

TECA/MEDELEC AS-10 SENSOR is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Teca, Inc.. The 510(k) number is K862906.

When did TECA/MEDELEC AS-10 SENSOR receive FDA 510(k) clearance?

TECA/MEDELEC AS-10 SENSOR received FDA 510(k) clearance on 1987-02-04, under 510(k) number K862906.

Who is the listed applicant for TECA/MEDELEC AS-10 SENSOR?

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/MEDELEC AS-10 SENSOR?

The FDA product code for TECA/MEDELEC AS-10 SENSOR is GWJ.

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: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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.

↑