SSA-320A JUST VISION 200/ SSA-325A JUST VISION

System, Imaging, Pulsed Echo, Ultrasonic

TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Ssa-320a Just Vision 200/ Ssa-325a Just Vision.

Pre-market Notification Details

Device IDK990490
510k NumberK990490
Device Name:SSA-320A JUST VISION 200/ SSA-325A JUST VISION
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin,  CA  92781 -2068
ContactPaul Biggins
CorrespondentCarole Stamp
TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1999-02-16
Decision Date1999-03-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987670001536 K990490 000
04987670001529 K990490 000
04987670001505 K990490 000
04987670001499 K990490 000
04987670001482 K990490 000
04987670001475 K990490 000
04987670000720 K990490 000
04987670000713 K990490 000

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