Device Classification Name |
Transmitters And Receivers, Electrocardiograph, Telephone
|
510(k) Number |
K024365 |
Device Name |
TM2005 PERSONAL MEDICAL PHONE CENTER |
Applicant |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PERERIS ST., SCIENCE PARK |
REHOVOT,
IL
76100
|
|
Applicant Contact |
ALEX GONOROVSKY |
Correspondent |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PERERIS ST., SCIENCE PARK |
REHOVOT,
IL
76100
|
|
Correspondent Contact |
ALEX GONOROVSKY |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 12/31/2002 |
Decision Date | 01/15/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|