Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K202189 |
Device Name |
Graffiti |
Applicant |
GE Medical Systems Information Technologies, Inc. |
9900 W Innovation Dr. |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
Camille Vidal |
Correspondent |
GE Medical Systems Information Technologies, Inc. |
9900 W Innovation Dr. |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Camille Vidal |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 08/04/2020 |
Decision Date | 12/08/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|