DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL


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

Correspodent Contact james p froehlich
Regulation Number 868.5905
Classification Product Code
BZD  
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