TOPOGRAPHIC BRAIN MAPPING OPTION— 510(k) K934050

Name: FDA 510(k) clearance K934050
Creator: U.S. Food and Drug Administration
Published: 1994-02-03

Substantially Equivalent

Biosound, Inc.

FDA 510(k) clearance K934050 for TOPOGRAPHIC BRAIN MAPPING OPTION, Substantially Equivalent on 1994-02-03. Applicant: Biosound, Inc.. Device class: 2.

Clearance details

Applicant: Biosound, Inc.
Product code: Product code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1993-08-19
Decision date: 1994-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biosound, Inc.

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K963662 — GALILEO EVOKED POTENTIALRE1997-02-26
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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.