| Device Classification Name |
ventilator, non-continuous (respirator)
|
|---|
| 510(K) Number |
K120920 |
|---|
| Models |
1125X,
11352;11353,
12000;12001;12002;12004;12005
|
| Device Name |
HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA |
|---|
| Applicant |
| HSINER COMPANY |
| 29201 via norte |
|
temecula,
CA
92591
|
|
| Contact |
tom shanks |
| Regulation Number | 868.5905
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/27/2012 |
|---|
| Decision Date | 07/16/2012 |
|---|
| 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
|
|---|
|
|
