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510(k) K020604

WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 by Nellcor Puritan Bennett, Inc. — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2002
Date Received
February 25, 2002
Clearance Type
Special
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 Nellcor Puritan Bennett, Inc.

  • K070899 — PURITAN BENNETT LEGENDAIR XL2 (December 13, 2007)
  • K070408 — DURAMAX REUSABLE OXIMETRY SENSOR (May 25, 2007)
  • K060576 — NELLCOR OXIMAX N-600X PULSE OXIMETER (August 14, 2006)
  • K051271 — OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR (January 10, 2006)
  • K052186 — NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P (November 10, 2005)
  • K051352 — OXIMAX NPB-40 HANDHELD PULSE OXIMETER (August 11, 2005)
  • K050072 — GOODKNIGHT 425ST (June 13, 2005)
  • K033973 — OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR (December 13, 2004)
  • K030787 — SHILEY FLEXTRA TRACHEOSTOMY TUBE (November 14, 2003)
  • K030930 — OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N (May 23, 2003)

Other clearances for product code DWJ

  • K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 2025)
  • K242964 — Celsi Warmer (June 20, 2025)
  • 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)