Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K142960 |
Device Name |
Propeller System 2014-R |
Applicant |
Reciprocal Labs |
634 W. Main Street, Suite 102 |
Madison,
WI
53703
|
|
Applicant Contact |
David Hubanks |
Correspondent |
Reciprocal Labs |
634 W. Main Street, Suite 102 |
Madison,
WI
53703
|
|
Correspondent Contact |
David Hubanks |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 10/14/2014 |
Decision Date | 03/05/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|