Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K172510 |
Device Name |
µCor Heart Failure and Arrhythmia Management System |
Applicant |
ZOLL Manufacturing Corporation |
121 Gamma Drive |
Pittsburgh,
PA
15238
|
|
Applicant Contact |
Dawn Chang |
Correspondent |
ZOLL Manufacturing Corporation |
2000 Ringwood Avenue |
San Jose,
CA
95131
|
|
Correspondent Contact |
Dawn Chang |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/21/2017 |
Decision Date | 05/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02975050 NCT03072732
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|