Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K042254 |
Device Name |
PMP4 SELFCHECK ECG |
Applicant |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PERERIS ST., SCIENCE PARK |
REHOVOT,
IL
76100
|
|
Applicant Contact |
NAAMA OREN |
Correspondent |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PERERIS ST., SCIENCE PARK |
REHOVOT,
IL
76100
|
|
Correspondent Contact |
NAAMA OREN |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 08/20/2004 |
Decision Date | 01/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|