FDA 510(k) Applications Submitted by NORMA J LEMAY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040074 |
01/14/2004 |
ONEVIEW INTERFACE |
NXSTAGE MEDICAL, INC. |
| K060296 |
02/06/2006 |
NXSTAGE DIALYSATE PREPARATION MODULE |
NXSTAGE MEDICAL, INC. |
| K030470 |
02/12/2003 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
| K180393 |
02/13/2018 |
AIRO Computed Tomography (CT) X-ray System |
Mobius Imaging, LLC |
| K050525 |
03/02/2005 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
| K040696 |
03/17/2004 |
MODIFICATION TO NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
| K020858 |
03/18/2002 |
NXSTAGE THERAPY SYSTEM |
NXSTAGE MEDICAL, INC. |
| K050727 |
03/21/2005 |
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
| K071263 |
05/07/2007 |
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 |
NXSTAGE MEDICAL, INC. |
| K131431 |
05/17/2013 |
AIRO CT SYSTEM |
MOBIUS IMAGING, LLC |
| K041424 |
05/28/2004 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
| K061837 |
06/29/2006 |
NXSTAGE CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
| K032356 |
07/30/2003 |
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
| K042045 |
07/30/2004 |
NXSTAGE PUREFLOW-B SOLUTION |
NXSTAGE MEDICAL, INC. |
| K042089 |
08/03/2004 |
NX STAGE WATER PURIFICATION SYSTEM |
NX STAGE MEDICAL INC |
| K022913 |
09/03/2002 |
NXSTAGE PREMIXED DIALYSATE |
NXSTAGE MEDICAL, INC. |
| K033386 |
10/23/2003 |
NXSTAGE PUREFLOW SOLUTION |
NXSTAGE MEDICAL, INC. |
| K103238 |
11/02/2010 |
1.5T OPTIMA MR430S |
GE MEDICAL SYSTEMS, LLC |
| K003510 |
11/14/2000 |
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 |
VISUALIZATION TECHNOLOGY, INC. |
| K053286 |
11/25/2005 |
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION |
NXSTAGE MEDICAL, INC. |
| K043436 |
12/13/2004 |
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 |
NXSTAGE MEDICAL, INC. |
| K014152 |
12/18/2001 |
NXSTAGE CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
| K994270 |
12/20/1999 |
INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 |
VISUALIZATION TECHNOLOGY, INC. |
| K160126 |
01/20/2016 |
AIRO Computed Tomography (CT) X-ray System |
Mobius Imaging |
| K984482 |
12/16/1998 |
AVE GL-1 GUIDING CATHETER |
ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC. |
|
|
