BIPAP A 40 VENTILATORY SUPPORT SYSTEM


Device Classification Name

ventilator, continuous, minimal ventilatory support,facility use

510(k) Number K121623
Device Name BIPAP A 40 VENTILATORY SUPPORT SYSTEM
Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Applicant Contact elaine larkin
Correspondent
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Correspodent Contact elaine larkin
Regulation Number 868.5895
Classification Product Code
MNT  
Date Received 06/01/2012
Decision Date 12/14/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No