Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K874395 |
Device Name |
RESPIRGARD II NEBULIZER SYSTEM |
Applicant |
MARQUEST MEDICAL PRODUCTS, INC. |
11039 EAST LANSING CIR. |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
JOHN ADAMS |
Correspondent |
MARQUEST MEDICAL PRODUCTS, INC. |
11039 EAST LANSING CIR. |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
JOHN ADAMS |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 10/28/1987 |
Decision Date | 12/21/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|