FDA-Device2022-04-13Class II
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Remote Diagnostic Technologies Ltd.
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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