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510(k) K945984

MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS by Meridian Medical Systems, Inc. — Product Code CAI

K945984 is an FDA 510(k) premarket notification submitted by Meridian Medical Systems, Inc. for the device "MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS". The FDA issued a decision of Substantially Equivalent on December 27, 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. Meridian Medical Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1994
Date Received
December 8, 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 Meridian Medical Systems, Inc.

  • K162687 — Paragon 2 (October 21, 2016)
  • K143232 — Universal Digital Interface 2W, UDI 2W (January 30, 2015)
  • K140251 — UNIVERSAL DIGITAL INTERFACE 2, UDI 2 (October 22, 2014)
  • K112527 — UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (May 22, 2012)
  • K111305 — UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W (January 31, 2012)
  • K103599 — UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (April 27, 2011)
  • K944157 — DISPOSABLE, PREFORMED FACE MASK (October 3, 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)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)

FDA data resources