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510(k) K913753

BODAI NEO2 -SAFE AIRWAY PRESSURE CAP by B&B Medical Technologies, Inc. — Product Code CAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
August 21, 1991
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

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  • K935171 — STABILTRACH (December 2, 1993)
  • K925386 — ADHESIVE E.T. TAPE (April 19, 1993)
  • K923690 — MINI HEART (October 20, 1992)
  • K913015 — HEART NEBULIZER FLOWMETER ADAPTOR (November 20, 1991)
  • K913000 — HEART NEBULIZER POLE CLAMP (August 2, 1991)

Other clearances for product code CAI

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  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)