| Device Classification Name |
Nebulizer (Direct Patient Interface)
|
| 510(k) Number |
K050104 |
| Device Name |
APEX MEDICAL MININEB & MINIPLUS |
| Applicant |
| Apex Medical Corp. |
| # 9, Minsheng St. |
|
Tucheng City, Taipei County,
TW
236
|
|
| Applicant Contact |
ANAN CHANG |
| Correspondent |
| Apex Medical Corp. |
| # 9, Minsheng St. |
|
Tucheng City, Taipei County,
TW
236
|
|
| Correspondent Contact |
ANAN CHANG |
| Regulation Number | 868.5630 |
| Classification Product Code |
|
| Date Received | 01/18/2005 |
| Decision Date | 02/16/2005 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Statement |
Statement
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|