CTS-200 WITH EZU-PL21 TRANSDUCER

System, Imaging, Pulsed Echo, Ultrasonic

SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instuments with the FDA for Cts-200 With Ezu-pl21 Transducer.

Pre-market Notification Details

Device IDK963068
510k NumberK963068
Device Name:CTS-200 WITH EZU-PL21 TRANSDUCER
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 1106 CHILTERN DR. Walnut Creek,  CA  94596
ContactRobert Morton
CorrespondentRobert Morton
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 1106 CHILTERN DR. Walnut Creek,  CA  94596
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-07
Decision Date1997-05-29
Summary:summary

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