Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K100383 |
Device Name |
VITAPHONE. MODEL 100 BT |
Applicant |
VITASYSTEMS GMBH |
STADLERSTRASSE 14 |
CHEMNITZ,
DE
09126
|
|
Applicant Contact |
TILO BORCHARDT |
Correspondent |
VITASYSTEMS GMBH |
STADLERSTRASSE 14 |
CHEMNITZ,
DE
09126
|
|
Correspondent Contact |
TILO BORCHARDT |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 02/16/2010 |
Decision Date | 04/20/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|