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510(k) K833196

VOLUME VENTILATOR CIRCUIT-NEBULIZER by Airlife, Inc. — Product Code CAI

K833196 is an FDA 510(k) premarket notification submitted by Airlife, Inc. for the device "VOLUME VENTILATOR CIRCUIT-NEBULIZER". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Airlife, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1983
Date Received
September 19, 1983
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 Airlife, Inc.

  • K834570 — VOLUME VENTILATOR CIRCUIT W/WATER TRAP (March 5, 1984)
  • K834573 — AQUA TRAP (March 5, 1984)
  • K834077 — SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN (December 12, 1983)
  • K833197 — TRACH SWIVE/CONNECTOR (October 28, 1983)
  • K832725 — DUAL DIAL VENTURI STYLE MASK (September 20, 1983)
  • K831246 — WHISTLER IN-LINE PRESSURE RELEASE VALVE (July 26, 1983)
  • K830895 — SINGLE USE NEBULIZER, ADJUST. AIR- (April 28, 1983)
  • K830896 — HUMIDIFIER, WITH OR WITHOUT ADAPTER (April 18, 1983)
  • K821129 — AIRLIFE NEBULIZER HEATER (May 18, 1982)
  • K821128 — DISPOSABLE THERMOPLASTIC RUBBER MOUTH (May 13, 1982)

Other clearances for product code CAI

  • K954480 — CONDENSATE COLLECTION KIT (December 29, 1995)
  • K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (September 19, 1995)
  • K953788 — UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (September 19, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)

FDA data resources