Device Classification Name |
electrocardiograph, ambulatory (without analysis)
|
510(k) Number |
K173156 |
Device Name |
Integrated CardioRespiratory System |
Applicant |
Sensydia, Inc. |
907 Westwood Boulevard, Suite 358 |
Los Angeles,
CA
90024
|
|
Applicant Contact |
Thomas Bruggere |
Correspondent |
Experien Group, LLC |
224 Airport Parkway, Suite 250 |
San Jose,
CA
95110
|
|
Correspondent Contact |
Anna Libman |
Regulation Number | 870.2800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 06/08/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|