Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K162905 |
Device Name |
SleepWeaver 3D Nasal Mask |
Applicant |
Circadiance, LLC |
1300 RODI RD |
TURTLE CREEK,
PA
15145
|
|
Applicant Contact |
JAMES GIANOUTSOS |
Correspondent |
Circadiance, LLC |
1300 RODI RD |
TURTLE CREEK,
PA
15145
|
|
Correspondent Contact |
JAMES GIANOUTSOS |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 10/17/2016 |
Decision Date | 03/15/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|