FDA.report

510(k) K210603

Device
3M Bair Hugger Temperature Management System (Model 675)
Applicant
3M Company
510(k) number
K210603
Product code
DWJ
Decision
Substantially Equivalent (SESE)
Decision date
2021-03-30
Date received
2021-03-01
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

Related Records

Applicant Contact

Contact
Brian Kleiber
Address
3m Center 2510 Conway Ave., Bldg. 275-5w-06 St. Paul MN US 55144 55144

FDA Registration Numbers

Source Documents

510(k) summary PDF

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