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510(k) K811413

DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR by Airco/Ohio Medical Products — Product Code CAI

K811413 is an FDA 510(k) premarket notification submitted by Airco/Ohio Medical Products for the device "DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR". The FDA issued a decision of Substantially Equivalent on June 2, 1981. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Airco/Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1981
Date Received
May 19, 1981
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 Airco/Ohio Medical Products

  • K833459 — COAXIAL VOL. VENTILATOR CIRCUIT (January 10, 1984)
  • K833452 — OHIO GMS ABSORBER (November 29, 1983)
  • K832418 — OHIO TEMPERATURE SIMULATOR (September 12, 1983)
  • K832565 — OHIO 5400 VOLUME MONITOR (September 1, 1983)
  • K832185 — OHIO MODEL 922 SPIROMETER (August 12, 1983)
  • K830446 — OXYGEN MONITOR OHIO 5100 (March 24, 1983)
  • K822456 — OHIO V5A ANESTHESIA VENTILATOR (September 21, 1982)
  • K813476 — OHIO VOLUME INCENTIVE SPIROMETER (December 31, 1981)
  • K812880 — OHIO NON-REUSABLE TRACHEAL TUBE MAJILL (November 24, 1981)
  • K812879 — OHIO NON-REUSABLE TRACHEAL TUBE MURPHY (November 24, 1981)

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