FDA 510(k) Applications Submitted by MARY LOU STROUMBOS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K122051 |
07/12/2012 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
| K140571 |
03/06/2014 |
NXSTAGE PUREFLOW SL |
NXSTAGE MEDICAL, INC. |
| K150472 |
02/23/2015 |
NxStage System One |
NXSTAGE MEDICAL, INC. |
| K140526 |
03/04/2014 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
| K140623 |
03/11/2014 |
NXSTAGE EXPRESS FLUID WARMER |
NXSTAGE MEDICAL, INC. |
| K081043 |
04/14/2008 |
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT |
NXSTAGE MEDICAL, INC. |
| K111174 |
04/27/2011 |
NXSTAGE PUREFLOW SL |
NXSTAGE MEDICAL, INC. |
| K131739 |
06/13/2013 |
NXSTAGE CONNECTED HEALTH SYSTEM |
NXSTAGE MEDICAL, INC. |
| K141752 |
06/30/2014 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
| K132602 |
08/20/2013 |
STREAMLINE EXPRESS |
NXSTAGE MEDICAL, INC. |
| K113023 |
10/11/2011 |
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER |
NXSTAGE MEDICAL, INC. |
| K123395 |
11/05/2012 |
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
| K133547 |
11/19/2013 |
NXSTAGE SYSTEM ONE WITH NXVIEW |
NXSTAGE MEDICAL, INC. |
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