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510(k) K242578

EVOLVE Nitric Oxide Delivery System by Mallinckrodt Manufacturing, LLC — Product Code MRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2025
Date Received
August 29, 2024
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 Mallinckrodt Manufacturing, LLC

  • K222930 — Evolve Nitric Oxide Delivery System (December 6, 2023)
  • K211153 — Inomax DSIR (April 20, 2023)
  • K200389 — INOmax DSIR Plus (June 17, 2020)

Other clearances for product code MRN

  • K242374 — ULSPIRA TS™ Nitric Oxide Therapy System (January 17, 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)
  • K200389 — INOmax DSIR Plus (June 17, 2020)