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510(k) K221634

Oxymag - Transport and Emergency Ventilator by Magnamed Tecnologia Medica S/A — Product Code BTL

K221634 is an FDA 510(k) premarket notification submitted by Magnamed Tecnologia Medica S/A for the device "Oxymag - Transport and Emergency Ventilator". The FDA issued a decision of Substantially Equivalent on May 24, 2023. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2023
Date Received
June 6, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances for product code BTL

  • K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (April 4, 2025)
  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (November 20, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)
  • K140049 — MOVES SLC (May 29, 2014)

FDA data resources