RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER

Echocardiograph

PHOENIX IMAGING

The following data is part of a premarket notification filed by Phoenix Imaging with the FDA for Resubmitted Ai 5200 Ultrasound Transducer.

Pre-market Notification Details

Device IDK883845
510k NumberK883845
Device Name:RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER
ClassificationEchocardiograph
Applicant PHOENIX IMAGING 4666 SOUTH ASH AVE. Tempe,  AZ  85282
ContactMichael Parsons
CorrespondentMichael Parsons
PHOENIX IMAGING 4666 SOUTH ASH AVE. Tempe,  AZ  85282
Product CodeDXK  
CFR Regulation Number870.2330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-12
Decision Date1989-02-03

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