Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K072136 |
Device Name |
ULTRASONIC NEBULISER MODEL 2010 |
Applicant |
WILFRED KROMKER GMBH |
S65 W35739 PIPER ROAD |
EAGLE,
WI
53119
|
|
Applicant Contact |
STEPHEN GORSKI |
Correspondent |
WILFRED KROMKER GMBH |
S65 W35739 PIPER ROAD |
EAGLE,
WI
53119
|
|
Correspondent Contact |
STEPHEN GORSKI |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 08/02/2007 |
Decision Date | 07/15/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|