FDA 510(k) Applications Submitted by Susan Hamann
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090004 |
01/02/2009 |
LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES |
LEVITRONIX LLC. |
| K090051 |
01/07/2009 |
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 |
LEVITRONIX LLC. |
| K040443 |
02/20/2004 |
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I |
DOME IMAGING SYSTEMS, INC. |
| K081221 |
04/30/2008 |
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE |
LEVITRONIX LLC. |
| K032202 |
07/18/2003 |
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I |
PLANAR SYSTEMS, INC. |
| K032638 |
08/27/2003 |
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY |
PLANAR SYSTEMS, INC. |
| K173181 |
09/29/2017 |
ExSpiron 1Xi |
Respiratory Motion Inc. |
| K083340 |
11/12/2008 |
LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE |
LEVITRONIX LLC. |
| K110274 |
01/31/2011 |
AUTODELFIA NEONATAL IRT KIT |
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. |
| K102419 |
08/25/2010 |
GSP NEONATAL IRT KIT (3306-001U) |
WALLAC OY, SUBSIDIARY OF PERKINELMER |
| K103484 |
11/26/2010 |
GSP NEONATAL THYROXINE (T4) |
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. |
| K093832 |
12/14/2009 |
LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES |
LEVITRONIX LLC. |
| K192595 |
09/20/2019 |
ExSpiron 2Xi |
Respiratory Motion |
|
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