Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K130626 |
Device Name |
MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
8200 WEST TOWER AVE. |
MILWAUKEE,
WI
53223
|
|
Applicant Contact |
PHILIP MALCA |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
8200 WEST TOWER AVE. |
MILWAUKEE,
WI
53223
|
|
Correspondent Contact |
PHILIP MALCA |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 03/08/2013 |
Decision Date | 05/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|