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510(k) K211153

Inomax DSIR by Mallinckrodt Manufacturing, LLC — Product Code MRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2023
Date Received
April 19, 2021
Clearance Type
Traditional
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 Mallinckrodt Manufacturing, LLC

  • K242578 — EVOLVE Nitric Oxide Delivery System (January 3, 2025)
  • K222930 — Evolve Nitric Oxide Delivery System (December 6, 2023)
  • K200389 — INOmax DSIR Plus (June 17, 2020)

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)
  • K220898 — NOxBOXi Nitric Oxide Delivery System (April 27, 2022)
  • K201339 — The NOxBOXi Nitric Oxide Delivery System (June 19, 2020)
  • K200389 — INOmax DSIR Plus (June 17, 2020)