Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K112220 |
Device Name |
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL |
Applicant |
DEVILBISS HEALTHCARE LLC |
100 DEVILBISS HEALTHCARE |
SOMERSET,
PA
15501
|
|
Applicant Contact |
JAMES P FROEHLICH |
Correspondent |
DEVILBISS HEALTHCARE LLC |
100 DEVILBISS HEALTHCARE |
SOMERSET,
PA
15501
|
|
Correspondent Contact |
JAMES P FROEHLICH |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 08/02/2011 |
Decision Date | 11/22/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|