FDA.reportPublic FDA data

510(k) K232502

Device
Cocoon Convective Warming System, Model CWS7000
Applicant
Care Essentials Pty, Ltd.
510(k) number
K232502
Product code
DWJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-21
Date received
2023-08-18
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
Abhay Sinha
Address
103 Mornington St. North Geelong AU 3215 3215

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
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K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.2025-10-24
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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
K2106053M Bair Hugger Universal Warming Gown made with Thinsulate Insulation3M Company2021-04-29