CLARISSA INFANT NCPAP CANNULA


Device Classification Name

ventilator, continuous, facility use

510(k) Number K032922
Device Name CLARISSA INFANT NCPAP CANNULA
Applicant
AIRWAYS LTD., INC.
p.o.box 558
cedar knolls, 
NJ 
07927

Applicant Contact richard j larkin
Correspondent
AIRWAYS LTD., INC.
p.o.box 558
cedar knolls, 
NJ 
07927

Correspodent Contact richard j larkin
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 09/22/2003
Decision Date 09/22/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No