FDA 510(k) Applications Submitted by E-Z-EM, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K011160 |
04/16/2001 |
E-Z EM PERCUPUMP 2001 CT INJECTOR |
E-Z-EM, INC. |
| K954926 |
10/26/1995 |
HM-CAP CONTROL PANEL |
E-Z-EM, INC. |
| K030854 |
03/18/2003 |
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 |
E-Z-EM, INC. |
| K041178 |
05/05/2004 |
EMPOWER TRANSFER SET, (CAT. NO. 7725) |
E-Z-EM, INC. |
| K961845 |
05/13/1996 |
PERCUPUMP II WITH EDA |
E-Z-EM, INC. |
| K062449 |
08/22/2006 |
EMPOWERMR INJECTOR SYSTEM, MODEL 9730 |
E-Z-EM, INC. |
| K013219 |
09/26/2001 |
PROTOCO2L INSUFFLATOR MODEL 6400 |
E-Z-EM, INC. |
| K053008 |
10/26/2005 |
E-Z-EM ENDOSCOPIC CO2 REGULATOR |
E-Z-EM, INC. |
| K071378 |
05/17/2007 |
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES |
E-Z-EM, INC. |
| K031571 |
05/20/2003 |
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 |
E-Z-EM, INC. |
| K974621 |
12/11/1997 |
PERCUPUMP II WITH EDA |
E-Z-EM, INC. |
| K063029 |
10/02/2006 |
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 |
E-Z-EM, INC. |
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