TOPOGRAPHIC BRAIN MAPPING OPTION— 510(k) K934050

Substantially Equivalent

Biosound, Inc.

FDA 510(k) clearance K934050 for TOPOGRAPHIC BRAIN MAPPING OPTION, Substantially Equivalent on 1994-02-03. Applicant: Biosound, Inc..

Clearance details

Applicant: Biosound, Inc.
Product code: Code OLT
Advisory panel: Neurology
Date received: 1993-08-19
Decision date: 1994-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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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.