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510(k) K952267

CRITERION, CRITERION I.V., MODIFIED by Nova-Ventrx — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1997
Date Received
May 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Nova-Ventrx

  • K954480 — CONDENSATE COLLECTION KIT (December 29, 1995)
  • K893760 — CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 (August 10, 1989)
  • K881207 — RES-Q 1, 2, 3, 4 AND 5 (August 15, 1988)
  • K870382 — DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 (March 6, 1987)
  • K863756 — MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT (November 13, 1986)
  • K850600 — CO-AX VENTILATOR CIRCUIT (May 2, 1985)
  • K842795 — MAXI-MISER HUMIDIFIER INSERT 1030 (October 4, 1984)
  • K842794 — MAXI-MISER HUMIDIFIER INSERT 1020 & 1021 (October 4, 1984)
  • K841571 — MAXI-MISER WATER TRANSFER SET 1021/1022 (May 30, 1984)
  • K841569 — MAXI-MISER HUMIDIFIER INSERT 1020 (May 30, 1984)

Other clearances for product code BZE

  • K243244 — Heated Breathing Tube (July 25, 2025)
  • 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)