| 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
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|