Device Classification Name |
electrocardiograph
|
510(k) Number |
K182093 |
Device Name |
ZOLL ECG Analysis Software |
Applicant |
ZOLL Manufacturing Corporation |
121 Gamma Drive |
pittsburgh,
PA
15238
|
|
Applicant Contact |
zachary nelson |
Correspondent |
ZOLL Manufacturing Corporation |
121 Gamma Drive |
pittsburgh,
PA
15238
|
|
Correspondent Contact |
zachary nelson |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 08/03/2018 |
Decision Date | 01/28/2019 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|