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510(k) K973747

CONTROLLED TEMPERATURE CABINET SYSTEM by Smith — Product Code LDQ

K973747 is an FDA 510(k) premarket notification submitted by Smith for the device "CONTROLLED TEMPERATURE CABINET SYSTEM". The FDA issued a decision of Substantially Equivalent on May 7, 1998. Smith has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1998
Date Received
October 1, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Smith

  • K973748 — TEMPO AND TEMP H20 (March 10, 1998)
  • K972123 — PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 (July 25, 1997)
  • K971092 — QA-ES (April 23, 1997)
  • K970555 — IL0292 DP ECHOPORT (March 17, 1997)

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)
  • 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