Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K170966 |
Device Name |
TONOPORT VI |
Applicant |
PAR Medizintechnik GmbH & Co. KG |
Sachsendamm 6 |
Berlin,
DE
10829
|
|
Applicant Contact |
Buelent Tek |
Correspondent |
PAR Medizintechnik GmbH & Co. KG |
Sachsendamm 6 |
Berlin,
DE
10829
|
|
Correspondent Contact |
Thomas Fischer |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 03/31/2017 |
Decision Date | 06/14/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|