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510(k) K934462

ADULT ANESTHESIA BREATHING CIRCUIT KITS by Zefon Medical Products — Product Code CAI

K934462 is an FDA 510(k) premarket notification submitted by Zefon Medical Products for the device "ADULT ANESTHESIA BREATHING CIRCUIT KITS". The FDA issued a decision of Substantially Equivalent (kit) on March 1, 1994. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Zefon Medical Products has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 1, 1994
Date Received
September 13, 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 Zefon Medical Products

  • K940220 — REBREATHER BAGS (May 27, 1994)
  • K930957 — ZEFON GAS SAMPLING LINES (July 2, 1993)
  • K924889 — ZEFON ADULT ANESTHESIA BREATHING CIRCUIT (March 19, 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