Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K051365 |
Device Name |
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 |
Applicant |
K-JUMP HEALTH CO., LTD. |
55 NORHTERN BLVD. |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
K-JUMP HEALTH CO., LTD. |
55 NORHTERN BLVD. |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 05/25/2005 |
Decision Date | 07/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|