FDA.report

510(k) K232638

Device
FilteredFlo Warming Blankets
Applicant
Iob Medical, Inc.
510(k) number
K232638
Product code
DWJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-24
Date received
2023-08-30
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
Y
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jonathan Kovach
Address
504 E Diamond Ave. Gaithersburg MD US 20877 20877

FDA Registration Numbers

Source Documents

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

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K231596IOB Temperature Management SystemIob Medical, Inc.2023-06-30
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