Device Classification Name |
Electrocardiograph
|
510(k) Number |
K082013 |
Device Name |
CLUE MEDICAL AND CLUE MEDICAL BASIC |
Applicant |
TELOVITAL GMBH TELEMEDIZIN |
901 KING ST., SUITE 200 |
ALEXANDRIA,
VA
22314
|
|
Applicant Contact |
Calley Herzog |
Correspondent |
TELOVITAL GMBH TELEMEDIZIN |
901 KING ST., SUITE 200 |
ALEXANDRIA,
VA
22314
|
|
Correspondent Contact |
Calley Herzog |
Regulation Number | 870.2340
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/15/2008 |
Decision Date | 11/10/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|