THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR— 510(k) K923860

Name: FDA 510(k) clearance K923860
Creator: U.S. Food and Drug Administration
Published: 1993-02-04

Substantially Equivalent

Biosound, Inc.

FDA 510(k) clearance K923860 for THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR, Substantially Equivalent on 1993-02-04. Applicant: Biosound, Inc.. Device class: 2.

Clearance details

Applicant: Biosound, Inc.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1992-07-31
Decision date: 1993-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K953716 — INTRACAVITY TRANSDUCERS1996-04-17

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