FDA 510(k) Applications Submitted by MELISSA ROBINSON
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K040458 |
02/23/2004 |
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K050583 |
03/07/2005 |
MODEL 250 SERIES MATERNAL/FETAL MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K031376 |
05/01/2003 |
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K021435 |
05/06/2002 |
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K022193 |
07/05/2002 |
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K032252 |
07/22/2003 |
MODEL 120 SERIES MATERNAL/FETAL MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K022482 |
07/29/2002 |
SENSA-CUFF, MODELS INFANT, CHILD, ADULT |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K022834 |
08/26/2002 |
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K133002 |
09/24/2013 |
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials |
ABBOTT POINT OF CARE INC. |
K033304 |
10/14/2003 |
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K153357 |
11/20/2015 |
i-STAT Alinity System with i-STAT Sodium test |
ABBOTT POINT OF CARE INC. |
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