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510(k) K780044

BREATHING CIRCUIT, BAIN by Respiratory Care, Inc. — Product Code CAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1978
Date Received
January 9, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device Class
Class I
Regulation Number
868.5240
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)
  • K881625 — CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL (June 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)

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  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)