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510(k) K945374

ACU-HALT by Eva-Health USA, Inc. — Product Code LDQ

K945374 is an FDA 510(k) premarket notification submitted by Eva-Health USA, Inc. for the device "ACU-HALT". The FDA issued a decision of Substantially Equivalent on August 9, 1995.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1995
Date Received
November 2, 1994
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)
  • K992258 — HOT SHOT FLUID WARMER IV FLUIDS (January 12, 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)
  • 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