FDA.report

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
N

Related Records

Applicant Contact

Contact
Abhay Sinha
Address
103 Mornington St. North Geelong AU 3215 3215

FDA Registration Numbers

Source Documents

510(k) summary PDF

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