NELLCOR INDGO MANUAL RESUSCITATOR


Device Classification Name

ventilator, emergency, manual (resuscitator)

510(k) Number K023494
Device Name NELLCOR INDGO MANUAL RESUSCITATOR
Original Applicant
NELLCOR PURITAN BENNETT, INC.
4280 hacienda dr.
pleasanton, 
CA 
94588 -2719

Original Contact gina to
Regulation Number 868.5915
Classification Product Code
BTM  
Date Received 10/18/2002
Decision Date 02/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No