CSBP-001A BODY ORGAN PERFUSION SYSTEM

System, X-ray, Tomography, Computed

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 Csbp-001a Body Organ Perfusion System.

Pre-market Notification Details

Device IDK081482
510k NumberK081482
Device Name:CSBP-001A BODY ORGAN PERFUSION SYSTEM
ClassificationSystem, X-ray, Tomography, Computed
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin,  CA  92781 -2068
ContactPaul Biggins
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-05-28
Decision Date2008-06-11
Summary:summary

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