MULTIPURPOSE TRANSDUCER RANGE

System, Imaging, Pulsed Echo, Ultrasonic

PIE DATA MEDICAL BV

The following data is part of a premarket notification filed by Pie Data Medical Bv with the FDA for Multipurpose Transducer Range.

Pre-market Notification Details

Device IDK874192
510k NumberK874192
Device Name:MULTIPURPOSE TRANSDUCER RANGE
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant PIE DATA MEDICAL BV PHILIPSWEG 1 Maastricht 6227 Aj,  NL
ContactRikers
CorrespondentRikers
PIE DATA MEDICAL BV PHILIPSWEG 1 Maastricht 6227 Aj,  NL
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-14
Decision Date1988-07-19

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