| Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
|---|
| 510(K) Number |
K122076 |
|---|
| Model |
2.0
|
| Device Name |
PERSONAL HEALTH CENTER (PHC) |
|---|
| Applicant |
| ADFLOW HEALTH NETWORKS INC |
| 3232 ibis st |
|
san diego,
CA
92103
|
|
| Contact |
glen feye |
| Regulation Number | 870.1130
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 07/16/2012 |
|---|
| Decision Date | 04/15/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Cardiovascular
|
|---|
| Review Advisory Committee |
Cardiovascular
|
|---|
| statement |
statement
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
