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510(k) Data Aggregation
K Number
K112116Device Name
DIGITAL CLINICAL THERMOMETER MODEL V901US
Manufacturer
Date Cleared
2011-10-04
(71 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
AMPEROR-ELECTRONIC(SZ) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Digital Thermometer Model V901US is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is intended for the adult and pediatric population.
The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature, or standard mode (actual determination of temperature).
Device Description
The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature, or standard mode (actual determination of temperature).
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K Number
K082266Device Name
DIGITAL CLINICAL THERMOMETER MODEL V9XX
Manufacturer
Date Cleared
2008-11-07
(88 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
AMPEROR-ELECTRONIC(SZ) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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