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510(k) K760819

CONDUCTIVE ANESTHESIA BREATHING CIRCUIT by Omnicon Medical Corp. — Product Code CAI

K760819 is an FDA 510(k) premarket notification submitted by Omnicon Medical Corp. for the device "CONDUCTIVE ANESTHESIA BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on October 27, 1976. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Omnicon Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1976
Date Received
October 12, 1976
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 Omnicon Medical Corp.

  • K823872 — EMERGENCY TRACHEOSTOMY KIT (January 21, 1983)
  • K820576 — MAINFLOW BACTERIA FILTER (March 18, 1982)
  • K820577 — ANESTHESIA BACTERIA FILTER (March 18, 1982)
  • K801804 — ANESTHESIA BACTERIA FILTER (August 13, 1980)
  • K801803 — MAINFLOW BACTERIA FILTER (August 13, 1980)
  • K772060 — PROTECT IV GARD (December 20, 1977)
  • K770136 — DISPOSABLE BACTERIA FILTER (February 14, 1977)
  • K770001 — AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S (January 12, 1977)
  • K760149 — CONDUCTIVE ANESTHSIA BREATH. CIRCUIT (July 19, 1976)

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