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FDA 510(k) Applications for Medical Device Product Code "OSP"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K101801
MONICA HEALTHCARE
MONICA AN24
02/03/2011
K112163
MONICA HEALTHCARE
MONICA IF24
08/30/2011
K112390
MONICA HEALTHCARE LTD.
MONICA AN24
07/13/2012
K140862
MONICA HEALTHCARE LTD.
MONICA NOVII WIRELESS PATCH SYSTEM
08/27/2014
K153262
NEMO HEALTHCARE BV
PUREtraceÖ
02/07/2017
K142583
OBMedical Company
LaborView LV1000
01/16/2015
K190798
OBMedical Company
LaborViewÖ LV1000 Wireless Electrode System
09/18/2020
K131889
PROMEDIC, INC.
EUM 100PRO
04/23/2014
K090145
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
SURECALL EMG LABOR MONITOR
01/25/2011
K130002
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
SURECALL LABOR MONITOR
06/28/2013
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