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510(k) K180375

The IQoolTM Warm System by Braincool AB — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2018
Date Received
February 12, 2018
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 Braincool AB

  • K232844 — The IQoolTM System (October 4, 2023)
  • DEN210027 — The Cooral System (October 14, 2022)
  • K162523 — The IQool System (May 3, 2017)

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  • K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
  • K232627 — HotDog Warming Mattress + Return Electrode (April 18, 2024)
  • K232502 — Cocoon Convective Warming System, Model CWS7000 (February 21, 2024)
  • K231211 — Medline ComfortTemp Patient Warming System (December 1, 2023)
  • K232638 — FilteredFlo Warming Blankets (October 24, 2023)
  • K232844 — The IQoolTM System (October 4, 2023)
  • K232508 — Barrier EasyWarm Active Self-Warming Blanket (September 15, 2023)
  • K231596 — IOB Temperature Management System (June 30, 2023)