AMAZROCK PTE. LTD.

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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

Amazrock - 08883000001749 Catalog Number :

Device Description : AMAZROCK Digital Infrared Thermometer Dual Mode supports temperature scan via Fo AMAZROCK Digital Infrared Thermometer Dual Mode supports temperature scan via Forehead or Eardrum Detection. It is designed for use with adults and children.Modern Design & Convenient to Use- Ergonometric design to facilitate easy use across all ages. - The back-light screen makes it very convenient to use at night or under dim lighting conditions.- Rapid and accurate reading with 1 second measurement time. - Forehead scan mode makes it convenient to measure temperature while your child is sleeping. - Eardrum temperature detection mode is only suitable for use for ages 3 months & above.- Easy & Comfortable use experience as compared with other thermometer(s). Simple operations with just 2 buttons - “Head” (Forehead temperature detection) or “Ear” (Eardrum temperature scan).- Supports 20 readings memory recall.- Comes with two AAA batteries for immediate use.

Device Class : 2

Duns Number: 659258748

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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