Natus Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
6
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K093304PROTEKTOR 32August 11, 2010
K093949OLYMPIC BRAINZ MONITOR MODEL OBM70001June 16, 2010
K090019NATUS NEUROWORKS, MODEL 104196February 22, 2010
K083371NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)December 8, 2009
K073665ALGO 5 NEWBORN HEARING SCREENERJanuary 25, 2008
K051869NEOBLUE COZY LED PHOTOTHERAPY SYSTEMOctober 7, 2005
K030823ALGO 3I NEWBORN HEARING SCREENERApril 9, 2003
K022196NATUS BLUE LIGHT PHOTOTHERAPY UNITSeptember 19, 2002
K013137ALGO 3 NEWBORN HEARING SCREENEROctober 16, 2001
K974805CO-STAT(TM) END TIDAL BREATH ANALYZERMarch 11, 1998
K935160MINIMUFFSFebruary 9, 1995
K936039ALGO-2 NEWBORN HEARING SCREENERJanuary 5, 1995