Device Classification Name |
Electrocardiograph
|
510(k) Number |
K110266 |
Device Name |
MAC 5500 HD, MAC 3500 |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC |
9900 INOVATION DRIVE |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
PATRICIA TAIGE |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC |
9900 INOVATION DRIVE |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
PATRICIA TAIGE |
Regulation Number | 870.2340 |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/28/2011 |
Decision Date | 04/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|