V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE


Device Classification Name

ventilator, continuous, facility use

510(k) Number K110083
Device Name V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
Applicant
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct.
carlsbad, 
CA 
92130

Applicant Contact mary funk
Correspondent
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct.
carlsbad, 
CA 
92130

Correspodent Contact mary funk
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 01/11/2011
Decision Date 01/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No