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510(k) Data Aggregation
K Number
K180767Device Name
FEMON Banana Thermometer
Manufacturer
Date Cleared
2019-01-22
(305 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Life Science Technology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FEMON Banana Thermometer is a battery operated electronic device with intended use of measuring human body temperature. This device is intended for armpit temperature measurement from ages 29 days and older.
Device Description
The FEMON Banana Thermometer is a thermometer composed of a body patch to be directly attached to the patient's skin on armpit. The temperature information is then to be retrieved from the patch to the mobile phone application via Bluetooth.
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