Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K042945 |
Device Name |
AURA CPAP SYSTEM |
Applicant |
AEIOMED INC. |
800 LEVANGER LANE |
STOUGHTON,
WI
53589
|
|
Applicant Contact |
Gary Syring |
Correspondent |
AEIOMED INC. |
800 LEVANGER LANE |
STOUGHTON,
WI
53589
|
|
Correspondent Contact |
Gary Syring |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 10/25/2004 |
Decision Date | 03/09/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|