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510(k) K110635

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2011
Date Received
March 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

  • K113272 — INOMAX DS(DELIVERY SYSTEMS (February 29, 2012)

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