ZONARE ZS3 And Z.Onepro Diagnostic 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 Zs3 And Z.onepro Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK150249
510k NumberK150249
Device Name:ZONARE ZS3 And Z.Onepro Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ZONARE MEDICAL SYSTEMS, INC. 420 NORTH BERNARDO AVENUE Mountain View,  CA  94043
ContactSteve Geerdes
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 Received2015-02-03
Decision Date2015-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944904092690 K150249 000
06944904090726 K150249 000

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