Duns Number:530875902
Device Description: The Infrared forehead thermometer is a non-contact infrared thermometer intended for the i The Infrared forehead thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.
Catalog Number
-
Brand Name
JZIKI Infrared Forehead Themometer
Version/Model Number
JZK-601
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
K203707
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
b7ef6623-2c7e-4615-ae99-22d80f1fc09f
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 2021
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. | 7 |