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510(k) K912065

DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED by Intertech Resources, Inc. — Product Code CAI

K912065 is an FDA 510(k) premarket notification submitted by Intertech Resources, Inc. for the device "DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Intertech Resources, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
April 26, 1991
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 Intertech Resources, Inc.

  • K961318 — 1ST RESPONSE DISPOSABLE MANOMETER (December 17, 1996)
  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (June 8, 1995)
  • K952169 — SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC (June 8, 1995)
  • K952062 — PFT FILTER (June 8, 1995)
  • K935036 — HEPA FILTERED HEAT AND MOISTURE EXCHANGER (January 25, 1994)
  • K930816 — HEPA FILTERED HME (July 1, 1993)
  • K922479 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED (October 30, 1992)

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

FDA data resources