NIOX ARTICLE NO: 02-1000


Device Classification Name

system,test,breath nitric oxide

510(k) Number DEN030001
Device Name NIOX ARTICLE NO: 02-1000
Original Applicant
AEROCRINE AB
16787 bernardo center dr.
suite a-1
san diego, 
CA 
92128

Original Contact sean m curry
Regulation Number 862.3080
Classification Product Code
MXA  
Date Received 03/18/2003
Decision Date 04/30/2003
Decision

an

(AN)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Post-NSE

Reviewed by Third Party No

Combination Product

No