Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K152882 |
Device Name |
Propeller System |
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 | 09/30/2015 |
Decision Date | 03/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|