FDA 510(k) Applications Submitted by ADRIENNE LENZ
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130007 |
01/02/2013 |
SLEEP PROFILER |
ADVANCED BRAIN MONITORING, INC. |
| K130013 |
01/02/2013 |
X4 SYSTEM |
ADVANCED BRAIN MONITORING INC. |
| K130123 |
01/17/2013 |
BASIC AND DOMINANT FLEX SUCTION PUMPS |
MEDELA AG |
| K140190 |
01/24/2014 |
NIGHT SHIFT |
ADVANCED BRAIN MONITORING, INC. |
| K120447 |
02/14/2012 |
X4 |
ADVANCED BRAIN MONITORING, INC. |
| K120450 |
02/14/2012 |
SLEEP PROFILER |
ADVANCED BRAIN MONITORING, INC. |
| K120734 |
03/09/2012 |
MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE |
MICROSOFT CORP. |
| K110705 |
03/14/2011 |
APNEA RISK EVALUATION SYSTEM (ARES) |
ADVANCED BRAIN MONITORING INC. |
| K090892 |
03/31/2009 |
GE DATEX-OHMEDA S/5 ADU CARESTATION |
GE HEALTHCARE FINLAND OY |
| K071097 |
04/18/2007 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
| K111194 |
04/28/2011 |
APNEA RISK EVALUATION SYSTEM (ARES) |
ADVANCED BRAIN MONITORING, INC. |
| K131383 |
05/14/2013 |
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE |
ADVANCED BRAIN MONITORING INC. |
| K081842 |
06/30/2008 |
ENGSTROM CARESTATION, ENGSTROM PRO |
DATEX-OHMEDA, INC. |
| K081844 |
06/30/2008 |
GE DATEX-OHMEDA AVANCE |
DATEX-OHMEDA, INC. |
| K081941 |
07/08/2008 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
| K141926 |
07/16/2014 |
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
MEDELA AG |
| K112514 |
08/30/2011 |
APNEA RISK EVALUATION SYSTEM (ARES) |
ADVANCED BRAIN MONITORING, INC. |
| K092864 |
09/17/2009 |
AESPIRE 7900, AESPIRE VIEW |
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
| K083098 |
10/17/2008 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
| K113678 |
12/14/2011 |
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
MEDELA AG |
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