| Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
|---|
| 510(K) Number |
K120144 |
|---|
| Model |
M3 AND M3A
|
| Device Name |
VITAL SIGNS MONITOR |
|---|
| Applicant |
| EDAN INSTRUMENTS INC |
| 3/f-b, nanshan medical |
| equipments park |
|
shenzhen,
|
|
| Contact |
randy jiang |
| Regulation Number | 870.1130
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 01/18/2012 |
|---|
| Decision Date | 02/14/2012 |
|---|
| 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
|
|---|
|
|
