Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K151683 |
Device Name |
SleepWeaver Advance Pediatric Nasal CPAP Mask |
Applicant |
Circadiance, LLC |
1060 Corporate Lane |
Export,
PA
15632
|
|
Applicant Contact |
David Groll |
Correspondent |
Regulatory & Quality Solutions, LLC |
2790 Mosside Blvd, Suite 800 |
Monroeville,
PA
15146
|
|
Correspondent Contact |
Pooja Roychoudhury |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 06/22/2015 |
Decision Date | 04/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|