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
|
|
|