Device Classification Name |
computer, blood-pressure
|
510(k) Number |
K160945 |
Device Name |
Endophys Blood Pressure Monitor |
Applicant |
ENDOPHYS HOLDINGS, LLC |
1601 ELM STREET |
Dallas,
TX
75201
|
|
Applicant Contact |
Rebecca K. Pine |
Correspondent |
ENDOPHYS HOLDINGS, LLC |
1601 ELM STREET |
Dallas,
TX
75201
|
|
Correspondent Contact |
Rebecca K. Pine |
Regulation Number | 870.1110
|
Classification Product Code |
|
Date Received | 04/05/2016 |
Decision Date | 09/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|