PLV CONTINUUM VENTILATOR, MODEL P1000


Device Classification Name

continuous, ventilator, home use

510(k) Number K022750
Device Name PLV CONTINUUM VENTILATOR, MODEL P1000
Original Applicant
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct.
carlsbad, 
CA 
92009

Original Contact mary funk
Regulation Number 868.5895
Classification Product Code
NOU  
Subsequent Product Code
CBK  
Date Received 08/19/2002
Decision Date 11/20/2003
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