TERASON USMART3400 ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

TERATECH CORP.

The following data is part of a premarket notification filed by Teratech Corp. with the FDA for Terason Usmart3400 Ultrasound System.

Pre-market Notification Details

Device IDK140834
510k NumberK140834
Device Name:TERASON USMART3400 ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant TERATECH CORP. 77-79 TERRACE HALL AVE. Burlington,  MA  01803
ContactBen Chiampa
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 Received2014-04-02
Decision Date2014-04-25
Summary:summary

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