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510(k) K200225

Device
Arctic Sun Stat Temperature Management System
Applicant
Medivance, Inc.
510(k) number
K200225
Product code
DWJ  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-28
Date received
2020-01-30
Regulation
870.5900
Classification name
System, Thermal Regulating
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jacquelyn Borinski
Address
321 S. Taylor Ave. Suite 200 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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