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510(k) K942136

M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS by Mag, Inc. — Product Code CAI

K942136 is an FDA 510(k) premarket notification submitted by Mag, Inc. for the device "M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS". The FDA issued a decision of Substantially Equivalent on June 22, 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. Mag, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1994
Date Received
May 3, 1994
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 Mag, Inc.

  • K942132 — M.A.G. INC. HYPERINFLATION SYSTEM (June 22, 1994)
  • K942129 — M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (June 22, 1994)
  • K942122 — PEDIATRIC ANESTHESIA CIRCUITS (June 22, 1994)
  • K942127 — M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITS (June 22, 1994)
  • K942125 — VOLUME VENTILATOR (June 22, 1994)
  • K942123 — M.A.G. INC. VENTILATOR HOSES (June 22, 1994)
  • K942133 — M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS (June 22, 1994)
  • K942126 — M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT (June 22, 1994)
  • K942124 — GAS SAMPLING LINES AND CONNECTORS CIRCUITS (June 22, 1994)
  • K942130 — M.A.G. INC. MAPLESON D CIRCUITS (June 22, 1994)

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