Envitec-Wismar GmbH

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K133064MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-May 2, 2014
K122290ENVITEC MYSIGN O OXYGEN MEASURING DEVICEJanuary 23, 2013
K102270ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDENFebruary 22, 2011
K090438REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEJuly 24, 2009
K082655ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106November 25, 2008
K070193ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIESMay 2, 2007
K060675ENVITEC REUSABLE SOFTIP Y SPO2 SENSORSJuly 17, 2006
K043463ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORSFebruary 11, 2005
K992215MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMarch 29, 2000