Device Classification Name |
Transmitters And Receivers, Electrocardiograph, Telephone
|
510(k) Number |
K001634 |
Device Name |
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 |
Applicant |
TZ MEDICAL, INC. |
15858 S.W. UPPER BOONES FERRY |
RD. |
LAKE OSWEGO,
OR
97035
|
|
Applicant Contact |
BYRON ZAHLER |
Correspondent |
TZ MEDICAL, INC. |
15858 S.W. UPPER BOONES FERRY |
RD. |
LAKE OSWEGO,
OR
97035
|
|
Correspondent Contact |
BYRON ZAHLER |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 05/26/2000 |
Decision Date | 12/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|