NON-PYROGENIC ULTRASOUND TRANSDUCER COVER

Transducer, Ultrasonic, Diagnostic

CIVCO MEDICAL INSTRUMENTS CO., INC.

The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Non-pyrogenic Ultrasound Transducer Cover.

Pre-market Notification Details

Device IDK131528
510k NumberK131528
Device Name:NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH Kalona,  IA  52247
ContactAmanda Stahle
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-05-28
Decision Date2013-06-11
Summary:summary

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