Home / 510(k) Clearances / K193481

510(k) K193481

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System by International Biomedical — Product Code MRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2020
Date Received
December 17, 2019
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 International Biomedical

  • K221154 — Infant Heel WarmerTM; Heel Snuggler® (October 7, 2022)
  • K221653 — InfaTherm Disposable Infant Warming Mattress (October 6, 2022)
  • K220742 — NxtGen Infant Transport Incubator (July 15, 2022)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173516 — NuBorne Infant Warmer (August 17, 2018)
  • K160238 — Airborne Phototherapy Light (June 14, 2016)
  • K140707 — LIFEBORNE INFANT RESUSCITATOR (May 28, 2014)
  • K103525 — A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103524 — VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WIT (April 15, 2011)

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)