INOMAX DSIR (DELIVERY SYSTEM)


Device Classification Name

apparatus, nitric oxide delivery

510(k) Number K110344
Device Name INOMAX DSIR (DELIVERY SYSTEM)
Applicant
INO THERAPEUTICS
2902 dairy drive
madison, 
WI 
53718

Applicant Contact larry lepley
Correspondent
INO THERAPEUTICS
2902 dairy drive
madison, 
WI 
53718

Correspodent Contact larry lepley
Regulation Number 868.5165
Classification Product Code
MRN  
Date Received 02/04/2011
Decision Date 06/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes