Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K062014 |
Device Name |
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB |
Applicant |
FLAEM NUOVA S.P.A. |
5 TIMBER LANE |
NORTH READING,
MA
01864
|
|
Applicant Contact |
MAUREEN O'CONNELL |
Correspondent |
FLAEM NUOVA S.P.A. |
5 TIMBER LANE |
NORTH READING,
MA
01864
|
|
Correspondent Contact |
MAUREEN O'CONNELL |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/17/2006 |
Decision Date | 03/22/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|