GOODKNIGHT 425ST


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K050072
Device Name GOODKNIGHT 425ST
Applicant
NELLCOR PURITAN BENNETT, INC.
4280 hacienda dr.
pleasanton, 
CA 
94588 -2719

Applicant Contact james bonds
Correspondent
NELLCOR PURITAN BENNETT, INC.
4280 hacienda dr.
pleasanton, 
CA 
94588 -2719

Correspodent Contact james bonds
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 01/12/2005
Decision Date 06/13/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No