| Device Classification Name |
Nebulizer (Direct Patient Interface)
|
| 510(k) Number |
K914152 |
| Device Name |
SIDESTREAM DRUG NEBULIZER |
| Applicant |
| Medic-Aid , Ltd. |
| Hook Lane, Pagham, |
|
Sussex, U.K. Po21 3pp,
GB
|
|
| Applicant Contact |
M. R POLLINGTON |
| Correspondent |
| Medic-Aid , Ltd. |
| Hook Lane, Pagham, |
|
Sussex, U.K. Po21 3pp,
GB
|
|
| Correspondent Contact |
M. R POLLINGTON |
| Regulation Number | 868.5630 |
| Classification Product Code |
|
| Date Received | 09/16/1991 |
| Decision Date | 05/05/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|