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510(k) Data Aggregation
K Number
K172861Date Cleared
2017-12-19
(90 days)
Product Code
Regulation Number
880.2910Type
SpecialPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The devices models DT-K11E, DT-11H, are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
Device Description
electronic clinical thermometer
AI/ML Overview
This is a 510(k) premarket notification for a digital thermometer, not an AI/ML powered device. As such, the document does not contain the information requested in the prompt regarding acceptance criteria and studies for AI/ML validation. The medical device in question is a simple electronic thermometer.
Therefore, I cannot provide the requested information from the provided text.
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