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510(k) K090958

INOMAX DS (DELIVERY SYSTEM) by Ino Therapeutics, LLC — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2009
Date Received
April 6, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Ino Therapeutics, LLC

  • K130605 — INOMAX DSIR (DELIVERY SYSTEM) (May 2, 2013)
  • K122689 — INOBLENDER (November 7, 2012)
  • 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)
  • 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)

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