FDA.reportPublic FDA data

510(k) K231596

Device
IOB Temperature Management System
Applicant
Iob Medical, Inc.
510(k) number
K231596
Product code
DWJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-30
Date received
2023-06-01
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
Yes

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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