Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K031908 |
Device Name |
MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) |
Applicant |
MED2000 S.R.L. |
55 NORTHERN BLVD., STE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
MED2000 S.R.L. |
55 NORTHERN BLVD., STE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 868.5630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/20/2003 |
Decision Date | 01/14/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|