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510(k) K941026

THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR by Thayer Medical Corp. — Product Code BZA

K941026 is an FDA 510(k) premarket notification submitted by Thayer Medical Corp. for the device "THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR". The FDA issued a decision of Substantially Equivalent on August 18, 1994. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Thayer Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1994
Date Received
March 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Airway (Extension)
Device Class
Class I
Regulation Number
868.5810
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)
  • 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)
  • K901739 — THAYER METERED DOSE INHALER DISPENSER/ADAPTER (October 9, 1990)
  • K900047 — THAYER SUCTION EVACUATION CONDENSATE COLLECTION (April 23, 1990)

Other clearances for product code BZA

  • K083702 — TRACH-ASSIST (March 5, 2009)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K954197 — DISPOSABLE FLEX TUBE (October 26, 1995)
  • K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (September 19, 1995)
  • K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (July 20, 1995)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K944532 — PRIMA, INC. VENTILATOR HOSES (December 2, 1994)
  • K944535 — PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (November 29, 1994)
  • K944534 — PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (November 29, 1994)
  • K942392 — AIRWAY CONNECTOR WITH FLEX TUBE (August 22, 1994)

FDA data resources