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510(k) K132202

DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET by Enthermics Medical Systems, Inc. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2013
Date Received
July 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Enthermics Medical Systems, Inc.

  • K091336 — IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNO (May 7, 2010)
  • K993797 — EC-7701 FLUID WARMING CABINET (January 20, 2000)
  • K963731 — TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT (April 22, 1997)

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