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510(k) K992258

HOT SHOT FLUID WARMER IV FLUIDS by Infra-Med Technologies, Inc. — Product Code LDQ

K992258 is an FDA 510(k) premarket notification submitted by Infra-Med Technologies, Inc. for the device "HOT SHOT FLUID WARMER IV FLUIDS". The FDA issued a decision of Substantially Equivalent on January 12, 2000.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2000
Date Received
July 6, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances for product code LDQ

  • K993797 — EC-7701 FLUID WARMING CABINET (January 20, 2000)
  • K981032 — PIV SYSTEM (September 2, 1998)
  • K973747 — CONTROLLED TEMPERATURE CABINET SYSTEM (May 7, 1998)
  • K955661 — ACU-HALT (December 30, 1996)
  • K955776 — ACU-LAB (June 5, 1996)
  • K945374 — ACU-HALT (August 9, 1995)
  • K944961 — PERSONAL ALARM SYSTEM (PAS) (August 7, 1995)
  • K942810 — PALCO LABS COLD POUCH (June 28, 1995)
  • K930884 — MEDICAL PROCEDURE TRAY, MODIFICATION (March 21, 1995)
  • K934703 — MEDICOOL PROTECTALL (January 26, 1994)

FDA data resources