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FDA 510(k) Applications Submitted by JANICE BROWN
FDA 510(k) Number
Submission Date
Device Name
Applicant
K080272
02/01/2008
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
BOSTON SCIENTIFIC CORP.
K993946
11/19/1999
PEGASYS ULTRA
ADAC LABORATORIES
K031064
04/03/2003
INVACARE POLARIS EX CPAP, MODEL ISP3000
INVACARE CORP.
K111862
06/30/2011
VIEWRAY SYSTEM
VIEWRAY INCORPORATED
K061874
07/03/2006
INVACARE'S TWILIGHT II NASAL MASKS
INVACARE CORP.
K102915
10/01/2010
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
VIEWRAY INCORPORATED
K960427
01/29/1996
ABBOTT CELL-DYN 3500R SYSTEM
SEQUOIA TURNER CORP.
K980614
02/02/1998
ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
ABBOTT LABORATORIES
K000908
03/21/2000
SKYLIGHT IMAGING SYSTEM
ADAC LABORATORIES
K991142
04/05/1999
CELL-DYN 1200 SYSTEM
ABBOTT LABORATORIES
K981342
04/13/1998
ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
ABBOTT LABORATORIES
K961439
04/15/1996
ABBOTT CELL-DYN 4000 SYSTEM
ABBOTT DIAGNOSTICS
K992444
07/22/1999
MODIFICATION OF: CELL-DYN 1200 SYSTEM
ABBOTT LABORATORIES
K002237
07/24/2000
P3IMRT TM
ADAC LABORATORIES
K955673
11/06/1995
CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
ABBOTT LABORATORIES
K993923
11/18/1999
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
ADAC LABORATORIES
K955715
11/30/1995
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
ABBOTT LABORATORIES
K111043
04/15/2011
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
BOSTON SCIENTIFIC CORP.
K982307
07/01/1998
WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
WALLAC, INC.
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