SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

MEDISON AMERICA, INC.

The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Sa 9900 Plus Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK032329
510k NumberK032329
Device Name:SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDISON AMERICA, INC. 11075 KNOTT AVE. Cypress,  CA  90630
ContactA. Robert Depalma
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-07-29
Decision Date2003-08-06
Summary:summary

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