SONACE 2000

System, Imaging, Pulsed Echo, Ultrasonic

MEDISON CO., LTD.

The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Sonace 2000.

Pre-market Notification Details

Device IDK923246
510k NumberK923246
Device Name:SONACE 2000
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDISON CO., LTD. 5319 RANDALL PLACE Fremont,  CA  94538
ContactMark Hayward
CorrespondentMark Hayward
MEDISON CO., LTD. 5319 RANDALL PLACE Fremont,  CA  94538
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-02
Decision Date1993-05-20

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