ZONARE ULTRA ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

ZONARE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Zonare Medical Systems, Inc. with the FDA for Zonare Ultra Ultrasound System.

Pre-market Notification Details

Device IDK082326
510k NumberK082326
Device Name:ZONARE ULTRA ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ZONARE MEDICAL SYSTEMS, INC. 420 NORTH BERNARDO AVENUE Mountain View,  CA  94043
ContactLinda J Moore
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-08-14
Decision Date2008-10-08
Summary:summary

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