THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER

Transducer, Ultrasonic, Diagnostic

MEDISON AMERICA, INC.

The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for The S-vna 5-8(b) Diagnostic Ultrasound Transducer.

Pre-market Notification Details

Device IDK984639
510k NumberK984639
Device Name:THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton,  CA  94588
ContactBob Leiker
CorrespondentBob Leiker
MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton,  CA  94588
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-31
Decision Date1999-07-12
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.