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510(k) K122689

INOBLENDER by Ino Therapeutics — Product Code MRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2012
Date Received
September 4, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ino Therapeutics

  • K130605 — INOMAX DSIR (DELIVERY SYSTEM) (May 2, 2013)
  • K121021 — INOMAX DS (DELIVERY SYSTEM) (September 24, 2012)
  • K110344 — INOMAX DSIR (DELIVERY SYSTEM) (June 24, 2011)
  • K093922 — INOMAX DS (April 15, 2010)
  • K092545 — INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (March 10, 2010)
  • K090958 — INOMAX DS (DELIVERY SYSTEM) (June 18, 2009)
  • K081691 — INOMAX DS (DELIVERY SYSTEM) (August 28, 2008)
  • K080484 — INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (August 6, 2008)
  • K071516 — INOMAX DS (October 3, 2007)
  • K070867 — INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (April 27, 2007)

Other clearances for product code MRO

  • K052663 — INO THERAPEUTICS INOBLENDER, MODEL 10004 (November 4, 2005)
  • K011874 — FADASIS MEDICAL FM-1 NO BLENDER (July 20, 2001)
  • K003665 — FADASSI MEDICAL FM-1 NO BLENDER (February 23, 2001)