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510(k) K071516

INOMAX DS by Ino Therapeutics, LLC — Product Code MRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2007
Date Received
June 4, 2007
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

  • 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)
  • 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)
  • K070867 — INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (April 27, 2007)

Other clearances for product code MRN

  • K242374 — ULSPIRA TS™ Nitric Oxide Therapy System (January 17, 2025)
  • K242578 — EVOLVE Nitric Oxide Delivery System (January 3, 2025)
  • K240410 — EVOLVE Nitric Oxide Delivery System (May 28, 2024)
  • K233251 — NOxBOXi Nitric Oxide Delivery System (May 23, 2024)
  • K222930 — Evolve Nitric Oxide Delivery System (December 6, 2023)
  • K231823 — NOxBOXi Nitric Oxide Delivery System (August 11, 2023)
  • K212409 — Ulspira TS Nitric Oxide Therapy System (June 30, 2023)
  • K211153 — Inomax DSIR (April 20, 2023)
  • K220898 — NOxBOXi Nitric Oxide Delivery System (April 27, 2022)
  • K201339 — The NOxBOXi Nitric Oxide Delivery System (June 19, 2020)