ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS


Device Classification Name

ventilator, continuous, facility use

510(k) Number K023350
Device Name ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
Original Applicant
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct.
carlsbad, 
CA 
92009

Original Contact mary funk
Regulation Number 868.5895
Classification Product Code
CBK  
Subsequent Product Code
BZG  
Date Received 10/07/2002
Decision Date 11/06/2002
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