COOL APPROACH LIMITED

COOL APPROACH LIMITED

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Filters

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) (2)

Premarket Exempt

No

Clear

Sovereign-Gear - 05060505400007 Catalog Number :

Device Description : A flexible tipped home-use waterproof digital thermometer.

Device Class : 2

Duns Number: 672138455

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Sovereign-Gear - 05060505400014 Catalog Number :

Device Description : A home-use infrared forehead thermometer.

Device Class : 2

Duns Number: 672138455

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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