Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K970035 |
Device Name |
JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 |
Applicant |
GRAHAM-FIELD, INC. |
55 NORTHERN BLVD. |
SUITE 410 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
GRAHAM-FIELD, INC. |
55 NORTHERN BLVD. |
SUITE 410 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 01/03/1997 |
Decision Date | 04/01/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|