| Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
|---|
| 510(K) Number |
K120430 |
|---|
| Device Name |
MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P |
|---|
| Applicant |
| MICROLIFE INTELLECTUAL PROPERTY GMBH |
| mdi consultants, inc. |
| 55 northern blvd., suite 200 |
|
great neck,
NY
11021
|
|
| Contact |
susan goldstein-falk |
| Regulation Number | 870.1130
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/13/2012 |
|---|
| Decision Date | 08/02/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Cardiovascular
|
|---|
| Review Advisory Committee |
Cardiovascular
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
