| Device Classification Name |
Nebulizer (Direct Patient Interface)
|
| 510(k) Number |
K924123 |
| Device Name |
SIDESTREAM DISPOSABLE |
| Applicant |
| Medic-Aid , Ltd. |
| 5 E. Pallant |
| Chichester, |
|
Sest Sussex Po19 1ts,
GB
|
|
| Applicant Contact |
MORTON R POLLINGTON |
| Correspondent |
| Medic-Aid , Ltd. |
| 5 E. Pallant |
| Chichester, |
|
Sest Sussex Po19 1ts,
GB
|
|
| Correspondent Contact |
MORTON R POLLINGTON |
| Regulation Number | 868.5630 |
| Classification Product Code |
|
| Date Received | 08/17/1992 |
| Decision Date | 11/16/1992 |
| 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
|
|
|