GALILEO HALLEY— 510(k) K970703

Substantially Equivalent

Biosound Esaote, Inc.

FDA 510(k) clearance K970703 for GALILEO HALLEY, Substantially Equivalent on 1997-05-19. Applicant: Biosound Esaote, Inc.. Device class: 2.

Clearance details

Applicant: Biosound Esaote, Inc.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1997-02-26
Decision date: 1997-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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