Infanttech

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

Clear

Smarttemp Bluetooth thermometer - 00852500005098 Catalog Number :

Device Description : The smarttemp’s continuous monitoring is the easiest way to track baby’s tempera The smarttemp’s continuous monitoring is the easiest way to track baby’s temperature all day/night long! It sends an alert to a smart phone when fever strikes, without disturbing baby and letting baby sleep—it also provides medication reminders and allows for record keeping of medicine dosages. It’s comfortable, reliable, and safe. Using Bluetooth technology, a parent can keep baby close, but not disturb them when checking their temperature.

Device Class : 2

Duns Number: 002175077

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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