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510(k) K963731

TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT by Enthermics Medical Systems, Inc. — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1997
Date Received
September 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermal Regulating
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Enthermics Medical Systems, Inc.

  • K132202 — DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET (December 6, 2013)
  • 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)

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