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510(k) K901739

THAYER METERED DOSE INHALER DISPENSER/ADAPTER by Thayer Medical Corp. — Product Code CAI

K901739 is an FDA 510(k) premarket notification submitted by Thayer Medical Corp. for the device "THAYER METERED DOSE INHALER DISPENSER/ADAPTER". The FDA issued a decision of Substantially Equivalent on October 9, 1990. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Thayer Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1990
Date Received
April 16, 1990
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 Thayer Medical Corp.

  • K102658 — MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTION (December 10, 2010)
  • K993101 — LITEAIRE (October 26, 2000)
  • K992722 — PRIMEAIRE (November 10, 1999)
  • K972237 — HAND HELD MEDISPACER (July 31, 1997)
  • K955805 — DUAL SPRAY MINISPACER (March 21, 1996)
  • K941026 — THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR (August 18, 1994)
  • K924535 — THAYER HAND HELD M.K.I. HOLDING CHAMBER (March 10, 1993)
  • K914283 — THAYER EXPANSION CHAMBER METERED DOSE INHALER (February 26, 1992)
  • K904917 — THAYER MIP ADAPTER (January 28, 1991)
  • K900047 — THAYER SUCTION EVACUATION CONDENSATE COLLECTION (April 23, 1990)

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