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510(k) K904917

THAYER MIP ADAPTER by Thayer Medical Corp. — Product Code BXR

K904917 is an FDA 510(k) premarket notification submitted by Thayer Medical Corp. for the device "THAYER MIP ADAPTER". The FDA issued a decision of Substantially Equivalent on January 28, 1991. The device falls under product code BXR (Meter, Airway Pressure (Inspiratory Force)), a Class II device regulated under 21 CFR 868.1780. Thayer Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1991
Date Received
October 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Airway Pressure (Inspiratory Force)
Device Class
Class II
Regulation Number
868.1780
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)
  • K901739 — THAYER METERED DOSE INHALER DISPENSER/ADAPTER (October 9, 1990)
  • K900047 — THAYER SUCTION EVACUATION CONDENSATE COLLECTION (April 23, 1990)

Other clearances for product code BXR

  • K081693 — NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (September 11, 2008)
  • K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (February 3, 2004)
  • K912946 — COLLINS DIGITAL PULMONARY MANOMETER (January 15, 1992)
  • K901998 — DIGITAL MANOMETER (DM 50) (July 25, 1990)
  • K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING (March 9, 1988)

FDA data resources