Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K083630 |
Device Name |
CLUE MEDICAL AND CLUE MEDICAL BASIC |
Applicant |
TELOVITAL GMBH TELEMEDIZIN |
901 KING ST., SUITE 200 |
ALEXANDRIA,
VA
22314
|
|
Applicant Contact |
CHERITA JAMES |
Correspondent |
TELOVITAL GMBH TELEMEDIZIN |
901 KING ST., SUITE 200 |
ALEXANDRIA,
VA
22314
|
|
Correspondent Contact |
CHERITA JAMES |
Regulation Number | 870.2920
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/08/2008 |
Decision Date | 04/23/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|