Duns Number:688454128
Device Description: The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) tomeasure forehead temperature. Its operation is based on measuring the natural thermal radiation emanating fromthe forehead and the adjacent surfaces. Its software performs a calculation that factors in room temperature, andthen a calculated temperature is displayed on the LCD.
Catalog Number
-
Brand Name
THERMOFINDER
Version/Model Number
FS-301
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130361
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
f9316855-9744-4aca-bf3c-08e4fc9af341
Public Version Date
April 21, 2022
Public Version Number
1
DI Record Publish Date
April 13, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |