Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K143677 |
Device Name |
DeVilbiss Intellipap2/DeVilbiss BLUE |
Applicant |
DeVilbiss Healthcare, LLC |
100 DeVilbiss Drive |
Somerset,
PA
15501
|
|
Applicant Contact |
Betty Miller |
Correspondent |
DeVilbiss Healthcare, LLC |
100 DeVilbiss Drive |
Somerset,
PA
15501
|
|
Correspondent Contact |
Betty Miller |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 12/24/2014 |
Decision Date | 09/18/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01797705
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|