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510(k) K932708

PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS by Precision Med Products, Ltd. — Product Code CAI

K932708 is an FDA 510(k) premarket notification submitted by Precision Med Products, Ltd. for the device "PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS". The FDA issued a decision of Substantially Equivalent on July 23, 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. Precision Med Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1993
Date Received
June 4, 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 Precision Med Products, Ltd.

  • K932710 — GAS SAMPLING LINES AND CONNECTORS (July 23, 1993)
  • K932709 — PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM (July 23, 1993)
  • K932707 — ADULT ANESTHESIA BREATHING CIRCUIT (July 23, 1993)
  • K932711 — PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS (July 23, 1993)
  • K932706 — PRECISION MED PRODUCTS LTD. VENTILATOR HOSE (July 23, 1993)
  • K932489 — PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR. (July 22, 1993)
  • K932497 — PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING (July 22, 1993)
  • K932488 — PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS (July 22, 1993)
  • K932712 — PRECISION MED PRODUCTS LTD VOLUME VENTILATORS (July 22, 1993)
  • K932486 — PMP, LTD. PEDIATRIC TEMPERATURE MONITORING CIRCUIT (July 21, 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