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
|