Device Classification Name |
Device, Positive Pressure Breathing, Intermittent
|
510(k) Number |
K051964 |
Device Name |
POWERNEB |
Applicant |
COMEDICA , INC. |
2300 MCDERMOTT ROAD |
SUITE 200-207 |
PLANO,
TX
75025
|
|
Applicant Contact |
KRISTA OAKES |
Correspondent |
COMEDICA , INC. |
2300 MCDERMOTT ROAD |
SUITE 200-207 |
PLANO,
TX
75025
|
|
Correspondent Contact |
KRISTA OAKES |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/20/2005 |
Decision Date | 12/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|