Duns Number:659258748
Device Description: AMAZROCK Digital Infrared Thermometer Dual Mode supports temperature scan via Forehead or 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.
Catalog Number
-
Brand Name
Amazrock
Version/Model Number
Amaz-HC1001401
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 06, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
K131243
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
c7161f12-33e3-4a1c-8c88-d9156a8168f8
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
June 30, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |