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Cas Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
32
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K190270FORE-SIGHT ELITE Tissue Oximeter ModuleOctober 21, 2019
K180003FORE-SIGHT ELITE Module Tissue OximeterMay 10, 2018
K150620740 SELECTMay 8, 2015
K143675FORE-SIGHT Elite Absolute Tissue OximeterApril 10, 2015
K140430740 SELECTJune 13, 2014
K133879FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETERApril 29, 2014
K130411740 SELECTMay 29, 2013
K123700FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETERApril 11, 2013
K112820FORE-SIGHT ABSOLUTE TISSUE OXIMETERJanuary 26, 2012
K094030FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MCDecember 23, 2010
K091452FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)August 21, 2009
K083892FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)March 19, 2009
K073036FORE-SIGHT, MC-2000 SERIESFebruary 25, 2008
K063087MODIFICATION TO MODEL 750 SERIES MONITORDecember 11, 2006
K061960FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040September 5, 2006
K051257ADULT CEREBRAL OXIMETER, MODEL 2040December 22, 2005
K051896MODEL 750E SERIES MONITORDecember 16, 2005
K050844750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL,June 23, 2005
K033048CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NJune 1, 2004
K000512OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010September 26, 2000