TECA NEUROMAPPER 386— 510(k) K894889

Name: FDA 510(k) clearance K894889
Creator: U.S. Food and Drug Administration
Published: 1989-12-22

Substantially Equivalent

Teca, Inc.

FDA 510(k) clearance K894889 for TECA NEUROMAPPER 386, Substantially Equivalent on 1989-12-22. Applicant: Teca, Inc.. Device class: 2.

Clearance details

Applicant: Teca, Inc.
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1989-08-01
Decision date: 1989-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantiville, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.