INOMAX DS(IR) (DELIVERY SYSTEM)


Device Classification Name

apparatus, nitric oxide delivery

510(k) Number K110635
Device Name INOMAX DS(IR) (DELIVERY SYSTEM)
Applicant
INO THERAPEUTICS LLC/DBA IKARIA
1060 allendale dr
port allen, 
LA 
70767

Applicant Contact larry lepley
Correspondent
INO THERAPEUTICS LLC/DBA IKARIA
1060 allendale dr
port allen, 
LA 
70767

Correspodent Contact larry lepley
Regulation Number 868.5165
Classification Product Code
MRN  
Date Received 03/04/2011
Decision Date 06/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes