| Device Classification Name |
ventilator, continuous, facility use
|
|---|
| 510(K) Number |
K121379 |
|---|
| Models |
NIC FM CPAP,
NIP FM CPAP
|
| Device Name |
PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY |
|---|
| Applicant |
| AIRON CORPORATION |
| 751 north dr ste 6 |
|
melbourne,
FL
32934
|
|
| Contact |
g. eric gjerde |
| Regulation Number | 868.5895
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/08/2012 |
|---|
| Decision Date | 10/11/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Anesthesiology
|
|---|
| Review Advisory Committee |
Anesthesiology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
