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510(k) K113272

INOMAX DS(DELIVERY SYSTEMS by Ino Therapeutics, LLC/Dba Ikaria — Product Code MRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2012
Date Received
November 4, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Nitric Oxide Delivery
Device Class
Class II
Regulation Number
868.5165
Review Panel
AN
Submission Type

Other clearances by Ino Therapeutics, LLC/Dba Ikaria

  • K110635 — INOMAX DS(IR) (DELIVERY SYSTEM) (June 23, 2011)

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