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510(k) Data Aggregation
K Number
K971994Device Name
B-D ASSURE EAR THERMOMETER
Manufacturer
Date Cleared
1998-05-01
(337 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON CONSUMER PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The B-D Assure Ear Thermometer is designed for home use to measure body temperature from the tympanic membrane.
The B-D Assure Ear Thermometer is designed for measuring body temperature in a home setting.
Device Description
The Becton Dickinson Infrared Thermometer is a device that measures patient body temperature by quantifying the infrared emission from the tympanic membrane.
In clinical application the end of the infrared thermometer is placed in the outer portion of the auditory canal, where the sensor can get a good view of the tympanic membrane. Placing the probe is very similar to the maneuver used to visualize the ear drum using an otoscope. There is no risk of eardrum injury because the probe is not long enough or small enough to be inserted too deep into the ear canal.
The most advantageous feature of infrared tympanic thermometry is that it takes very little time. Readings can be taken in a few seconds.
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