Terason USmart 3200T Plus Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Teratech Corporation

The following data is part of a premarket notification filed by Teratech Corporation with the FDA for Terason Usmart 3200t Plus Ultrasound System.

Pre-market Notification Details

Device IDK201633
510k NumberK201633
Device Name:Terason USmart 3200T Plus Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Teratech Corporation 77-79 Terrace Hall Ave. Burlington,  MA  01803
ContactBenjamin Chiampa
CorrespondentPrithul Bom
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)
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-06-16
Decision Date2020-07-02

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