Device Classification Name |
Transmitters And Receivers, Electrocardiograph, Telephone
|
510(k) Number |
K051960 |
Device Name |
CARDIONAVIGATOR + |
Applicant |
DEL MAR REYNOLDS MEDICAL, LTD. |
377 ROUTE 17 S |
HASBROUCK HEIGHTS,
NJ
07604
|
|
Applicant Contact |
GEORGE MYERS |
Correspondent |
DEL MAR REYNOLDS MEDICAL, LTD. |
377 ROUTE 17 S |
HASBROUCK HEIGHTS,
NJ
07604
|
|
Correspondent Contact |
GEORGE MYERS |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 07/19/2005 |
Decision Date | 08/19/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|