Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K052941 |
Device Name |
I-NEB INSIGHT AAD SYSTEM |
Applicant |
PROFILE THERAPEUTICS PLC |
CORPORATE SERVICES |
1010 MURRY RIDGE LANE |
MURRYSVILLE,
PA
15668 -8525
|
|
Applicant Contact |
BARBARA CAMPBELL |
Correspondent |
PROFILE THERAPEUTICS PLC |
CORPORATE SERVICES |
1010 MURRY RIDGE LANE |
MURRYSVILLE,
PA
15668 -8525
|
|
Correspondent Contact |
BARBARA CAMPBELL |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 10/20/2005 |
Decision Date | 12/09/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|