FDA-Device2022-04-13Class II
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Hazard
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Sold states
US Nationwide distribution in the states of IL and KS.
Affected count
2
Manufactured in
PAVILION C2, ASHWOOD PARK, ASHWOOD WAY, Basingstoke, United Kingdom
Products
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0861-2022Don't want to check this manually?
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