FDA.report

510(k) K232627

Device
HotDog Warming Mattress + Return Electrode
Applicant
Augustine Temperature Management, LLC
510(k) number
K232627
Product code
DWJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-18
Date received
2023-08-29
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Garrett Augustine
Address
7656 W. 78th St. Minneapolis MN US 55439 55439

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code DWJ

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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