Device Classification Name |
electrocardiograph
|
510(k) Number |
K863535 |
Device Name |
LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. |
Applicant |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
3555 WOODHEAD DR. |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
GARY W HENDRICKSON |
Correspondent |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
3555 WOODHEAD DR. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
GARY W HENDRICKSON |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 09/11/1986 |
Decision Date | 01/06/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|