Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K133534 |
Device Name |
MCKESSON CARDIOLOGY ECG MOBILE |
Applicant |
MCKESSON ISRAEL LTD. |
5995 WINDWARD PARKWAY |
ALPHARETTA,
GA
30005
|
|
Applicant Contact |
PAUL SUMNER |
Correspondent |
MCKESSON ISRAEL LTD. |
5995 WINDWARD PARKWAY |
ALPHARETTA,
GA
30005
|
|
Correspondent Contact |
PAUL SUMNER |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 11/18/2013 |
Decision Date | 04/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|