DMR/CO2 COMBO KTI


Device Classification Name

ventilator, emergency, manual (resuscitator)

510(k) Number K960468
Device Name DMR/CO2 COMBO KTI
Applicant
NELLCOR PURITAN BENNETT, INC.
4280 hacienda dr.
pleasanton, 
CA 
94588 -2719

Applicant Contact sheryll a mathews
Correspondent
NELLCOR PURITAN BENNETT, INC.
4280 hacienda dr.
pleasanton, 
CA 
94588 -2719

Correspodent Contact sheryll a mathews
Regulation Number 868.5915
Classification Product Code
BTM  
Date Received 02/01/1996
Decision Date 04/26/1996
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No