Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K140638 |
Device Name |
PROPELLER SYSTEM - MODEL 2 |
Applicant |
RECIPROCAL LABS CORPORATION |
634 W Main St Ste 102 |
Madison,
WI
53703
|
|
Applicant Contact |
J. DAVID SICKLE |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 03/12/2014 |
Decision Date | 05/02/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|