| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
|---|
| 510(k) Number |
K012647 |
|---|
| Device Name |
TONOPORT V |
|---|
| Applicant |
| Par Medizintechnik GmbH |
| Einemstrasse 9 |
|
Berlin,
DE
D-10787
|
|
| Applicant Contact |
LOTHAR ENGEL |
| Correspondent |
| Par Medizintechnik GmbH |
| Einemstrasse 9 |
|
Berlin,
DE
D-10787
|
|
| Correspondent Contact |
LOTHAR ENGEL |
| Regulation Number | 870.1130 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/13/2001 |
|---|
| Decision Date | 11/09/2001 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
Cardiovascular
|
|---|
| Summary |
Summary
|
| Type |
Abbreviated
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|