PHASED ARRAY TRANSDUCER - - PSK-20CT

Transducer, Ultrasonic, Diagnostic

TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Phased Array Transducer - - Psk-20ct.

Pre-market Notification Details

Device IDK970047
510k NumberK970047
Device Name:PHASED ARRAY TRANSDUCER - - PSK-20CT
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin,  CA  92781 -2068
ContactSteven M Kay
CorrespondentSteven M Kay
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin,  CA  92781 -2068
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-06
Decision Date1997-03-04
Summary:summary

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