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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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modification to isola spinal system DEPUY ACROMED k022285 08/13/2002
encircle localization device VIVANT MEDICAL, INC. k022286 10/11/2002
3t/sewoon temperature sensing foley catheters 3T MEDICAL SYSTEMS, LLC. k022287 09/23/2002
complexed prostate specific antigen (cpsa) assay for the bayer advia integrated module system BAYER CORP. k022288 12/17/2002
protein s ac DADE BEHRING, INC. k022290 08/27/2002
impax diagnostic display station,impax clinical review station,impax for cardiology clinical review satation,impax ortho AGFA CORP. k022292 09/12/2002
apneacheck IM SYSTEMS k022294 04/25/2003
g-rinse, model 10031 VITROLIFE SWEDEN AB k022295 09/12/2002
modification to en-bloc biopsy system NEOTHERMIA CORP. k022296 07/30/2002
global ecg management system (gems) CARDIOCOMM SOLUTIONS, INC. k022297 09/27/2002

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