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510(k) K881625

CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL by Respiratory Care, Inc. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1988
Date Received
April 12, 1988
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 Respiratory Care, Inc.

  • K892230 — RCI VIRAL/BACTERIAL FILTER (August 28, 1989)
  • K884150 — MODIFIED CONCHATHERM III CONTROLLED HEATER (November 21, 1988)
  • K864147 — AQUAVALVE (December 5, 1986)
  • K863955 — COLBY LEVEL ALARM (November 7, 1986)
  • K861555 — CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT (June 5, 1986)
  • K834151 — CONCHATHERM LHF HUMIDIFIER HEATER (January 13, 1984)
  • K833974 — AQUAPAK 020 HUMIDIFIER ADAPTER (December 16, 1983)
  • K832453 — SLIMB SINGLE LIMB BREATHING CIRCUIT (October 27, 1983)
  • K811524 — AQUACADE (July 1, 1981)
  • K811073 — A QUAPAK (April 29, 1981)

Other clearances for product code BZE

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  • 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)