APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM


Device Classification Name

system,test,breath nitric oxide

510(k) Number K073265
Device Name APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
Applicant
APIERON, INC.
155 jefferson drive
menlo park, 
CA 
94025

Applicant Contact richard lotti
Correspondent
APIERON, INC.
155 jefferson drive
menlo park, 
CA 
94025

Correspodent Contact richard lotti
Regulation Number 862.3080
Classification Product Code
MXA  
Date Received 11/20/2007
Decision Date 03/14/2008
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