Duns Number:421279648
Device Description: EFT-161 measures the body temperature through receiving the infrared energy radiation from EFT-161 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode,and ear temperature mode. The measurement result directly shows on the LCD screen, It is easy, hygiene and accurate. The device is widely used for home healthcare, medical institutes and many other occasions.
Catalog Number
-
Brand Name
North American Health Wellness
Version/Model Number
JB8408
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
K171214
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
483f1795-e338-4dcb-83f9-81b44f869d71
Public Version Date
August 30, 2019
Public Version Number
1
DI Record Publish Date
August 22, 2019
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. | 9 |