NIOX MINO


Device Classification Name

system,test,breath nitric oxide

510(k) Number K072816
Device Name NIOX MINO
Applicant
AEROCRINE AB
801 pennsylvania ave.
washington, 
DC 
20004

Applicant Contact joel slomoff
Correspondent
AEROCRINE AB
801 pennsylvania ave.
washington, 
DC 
20004

Correspodent Contact joel slomoff
Regulation Number 862.3080
Classification Product Code
MXA  
Date Received 10/02/2007
Decision Date 03/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No