Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K092362 |
Device Name |
SLEEPWEAVER NASAL CPAP MASK |
Applicant |
CIRCADIANCE LLC |
3554 NORTH HILLS RD. |
MURRYSVILLE,
PA
15668
|
|
Applicant Contact |
DAVID GROLL |
Correspondent |
CIRCADIANCE LLC |
3554 NORTH HILLS RD. |
MURRYSVILLE,
PA
15668
|
|
Correspondent Contact |
DAVID GROLL |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 08/04/2009 |
Decision Date | 11/02/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|