FDA.reportPublic FDA data

AEON

Primary DI
06947832500442
Brand
AEON
Company
SHENZHEN AEON TECHNOLOGY CO., LTD.
Model
A202
Published
2026-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171578000Infrared thermometerShenzhen Aeon Technology Co., Ltd.2017-11-30FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947832500442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947832500442069478325004426947832500442

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, earA hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.

Regulatory Flags#

DUNS number
529372064
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947832500008AEONA2012026-04-30
06947832500015AEONA3102026-04-22
06947832500039AEONA3102018-09-28
06947832500046AEONA2012018-11-23
06947832500077AEONA3102019-09-18
06947832500084AEONA310L2019-09-18
06947832500091AEONA340L2020-04-21
06947832500107AEONA3402019-09-18
06947832500121AEONA340L2019-09-18
06947832500305AEONA3502019-09-18
06947832500350AEONA3202019-09-18
06947832500367AEONA3302019-09-18
06947832500374AEONA330N2019-09-18
06947832500381AEONA3402020-04-16
06947832500398AEONA310B2020-09-26
06947832500428AEONA330B2020-09-26
06947832500473AEONA340B2021-10-12
06947832500572AEONA201W2026-04-30
06947832500589AEONA201F2026-04-30
06947832500596AEONA202W2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
00885403523437HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
06970289030859foreverlittleHetaida Technology Co., LtdFLL2026-07-28
06953825911638ZKZOShenzhen Urion Technology Co., LtdFLL2026-07-23
B353UB25511UbiqVue MultiparameterLifesignals, Inc.FLL2026-07-20
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758508865CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28