ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT— 510(k) K042619

Name: FDA 510(k) clearance K042619
Creator: U.S. Food and Drug Administration
Published: 2004-11-05

Substantially Equivalent

Sonotech, Inc.

FDA 510(k) clearance K042619 for ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT, Substantially Equivalent on 2004-11-05. Applicant: Sonotech, Inc.. Device class: 2.

Clearance details

Applicant: Sonotech, Inc.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2004-09-24
Decision date: 2004-11-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Bellingham, WA, 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.