Inovise Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K151433AUDICOR CA300/CC100 Analyzer with SDBMarch 18, 2016
K131883AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)April 11, 2014
K130660AUDICOR CPAM WITH SDB (SINGLE SENSOR)October 11, 2013
K120462AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)September 20, 2012
K110569AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)October 24, 2011
K103516AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0February 4, 2011
K080602AUDICOR SENSOR, MODELS: 2.0, 3.0September 25, 2008
K073545AUDICOR, HEMO AMBULATORY MONITORSeptember 9, 2008
K070136AUDICOR 200 SYSTEM, MODELS 200D AND 200SApril 13, 2007
K051450EXTENDED MEASUREMENTS SYSTEMNovember 10, 2005
K043074LIBERTY SYSTEMFebruary 22, 2005
K032145AUDICOR UPGRADE SYSTEMOctober 31, 2003
K030316AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)August 7, 2003
K001349CARDIOVISE ECG INTERPRETATIVE SOFTWAREJuly 27, 2000