Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K072137 |
Device Name |
AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB |
Applicant |
AVITA CORPORATION |
2904 N. BOLDT DR. |
FLAGSTAFF,
AZ
86001
|
|
Applicant Contact |
JENNIFER REICH |
Correspondent |
AVITA CORPORATION |
2904 N. BOLDT DR. |
FLAGSTAFF,
AZ
86001
|
|
Correspondent Contact |
JENNIFER REICH |
Regulation Number | 870.1130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/02/2007 |
Decision Date | 12/07/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|