Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K915211 |
Device Name |
MICROCHAMBER |
Applicant |
RESPIRATORY DELIVERY SYSTEMS, INC. |
70 MOUNT HOPE ST. |
LOWELL,
MA
01854
|
|
Applicant Contact |
WALTER J MAKIEJ |
Correspondent |
RESPIRATORY DELIVERY SYSTEMS, INC. |
70 MOUNT HOPE ST. |
LOWELL,
MA
01854
|
|
Correspondent Contact |
WALTER J MAKIEJ |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 11/18/1991 |
Decision Date | 05/20/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|