Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K102507 |
Device Name |
AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR |
Applicant |
TZ MEDICAL, INC. |
7272 SW DURHAM RD., #800 |
PORTLAND,
OR
97224
|
|
Applicant Contact |
JOHN LUBISICH |
Correspondent |
TZ MEDICAL, INC. |
7272 SW DURHAM RD., #800 |
PORTLAND,
OR
97224
|
|
Correspondent Contact |
JOHN LUBISICH |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 09/01/2010 |
Decision Date | 06/13/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|