GALILEO EVOKED POTENTIALRE— 510(k) K963662

Name: FDA 510(k) clearance K963662
Creator: U.S. Food and Drug Administration
Published: 1997-02-26

Substantially Equivalent

Biosound, Inc.

FDA 510(k) clearance K963662 for GALILEO EVOKED POTENTIALRE, Substantially Equivalent on 1997-02-26. Applicant: Biosound, Inc.. Device class: 2.

Clearance details

Applicant: Biosound, Inc.
Product code: Code GWF
Device class: Class 2
Regulation: 21 CFR 882.1870
Advisory panel: Neurology
Date received: 1996-09-13
Decision date: 1997-02-26
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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K971700 — BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER1997-07-09
K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER1997-03-31
K963262 — ARTOSCAN M1997-03-28
K953716 — INTRACAVITY TRANSDUCERS1996-04-17
K953530 — DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A1996-04-08

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.