Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K172801 |
Device Name |
ECG SENTINEL System |
Applicant |
Cardiomedix, Inc. |
1840 Oak Ave. |
Evanston,
IL
60201
|
|
Applicant Contact |
Zipora David |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 09/18/2017 |
Decision Date | 10/18/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|