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510(k) K002577

Device
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS
Applicant
MEDIVANCE, INC.
510(k) number
K002577
Product code
DWJ  
Decision
Substantially Equivalent (SESE)
Decision date
2000-10-26
Date received
2000-08-18
Regulation
870.5900
Classification name
System, Thermal Regulating
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT A KLINE
Address
500 S. Arthur Ave., Suite 100 Louisville CO US 80027 80027

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DWJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260903Hot Pink Pad Warming SystemXodus Medical, Inc.2026-04-16
K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.2026-04-07
K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.2025-10-24
K242964Celsi WarmerHadleigh Health Technologies2025-06-20
K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.2025-04-30
K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC2024-04-18
K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd.2024-02-21
K231211Medline ComfortTemp Patient Warming SystemMedline Industries, LP2023-12-01
K232638FilteredFlo Warming BlanketsIob Medical, Inc.2023-10-24
K232844The IQoolTM SystemBraincool AB2023-10-04
K232508Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC2023-09-15
K231596IOB Temperature Management SystemIob Medical, Inc.2023-06-30
K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC2023-06-29
K221669IOB Warming BlanketsIob Medical, Inc.2022-12-27
K220941HotDog Temperature Management SystemAugustine Temperature Management2022-09-23

Legacy Summary#

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FDA Review#

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