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510(k) K150900

Flexicare Heated Wire Breathing Systems by Flexicare Medical, Ltd. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2015
Date Received
April 3, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
Submission Type

Other clearances by Flexicare Medical, Ltd.

  • K140473 — DUALGUARD (April 10, 2014)
  • K140113 — O2 NASAL CANNULA WITH CO2 MONITORING (March 6, 2014)
  • K132619 — CLASSIC INTERMITTENT CATHETER (October 11, 2013)
  • K092218 — FLEXICARE BREATHING FILTERS (October 6, 2009)
  • K091591 — FLEXICARE MEDICAL ENDOTRACHEAL TUBES (June 17, 2009)
  • K951652 — VENTIMASK MK IV (April 27, 1995)

Other clearances for product code BZE

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  • K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) (August 2, 2024)
  • K234032 — Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD9903 (June 4, 2024)
  • K222822 — VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (M (June 14, 2023)
  • K201418 — Sunset Heated CPAP Tube (January 29, 2021)
  • K173280 — Neonatal ConchaSmart Breathing Circuits (August 2, 2018)
  • K170378 — AirLife Adult Heated Wire BiPAP/NIV Circuit (September 14, 2017)
  • K153234 — AirLife Adult Heated Wire Circuit (July 7, 2016)
  • K160540 — FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM (June 23, 2016)
  • K151461 — Hybernite RT (March 24, 2016)