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510(k) K932192

PEDIATRIC ANESTHESIA CIRCUITS by Life Shield Healthcare Products, Inc. — Product Code CAI

K932192 is an FDA 510(k) premarket notification submitted by Life Shield Healthcare Products, Inc. for the device "PEDIATRIC ANESTHESIA CIRCUITS". The FDA issued a decision of Substantially Equivalent on July 2, 1993. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Life Shield Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1993
Date Received
May 6, 1993
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 Life Shield Healthcare Products, Inc.

  • K932562 — GAS SAMPLING LINES AND CONNECTORS (July 23, 1993)
  • K932561 — GUEDEL AIRWAYS (July 22, 1993)
  • K932557 — HYPERINFLATION SYSTEM (July 22, 1993)
  • K932560 — VOLUME VENTILATORS (July 22, 1993)
  • K932558 — ADULT ANESTHESIA BREATHING CIRCUIT (July 22, 1993)
  • K932559 — MAPLESON D CIRCUITS (July 16, 1993)
  • K932563 — VENTILATOR HOSES (July 16, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)
  • K932195 — ADULT GAS SAMPLING CIRCUITS (July 2, 1993)
  • K932197 — CUSTOM ANESTHESIA CIRCUITS (July 2, 1993)

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