FDA.reportPublic FDA data

Infrared Thermometer

Primary DI
06953205900825
Brand
Infrared Thermometer
Company
Shenzhen Jiacom Technology Co., Ltd
Model
FR830
Published
2018-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K172874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172874000Infrared ThermometerShenzhen Jiacom Technology CO ., Ltd.2018-07-12FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06953205900825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06953205900825069532059008256953205900825

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421098256
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06953205995043Infrared ThermometerFR8002026-03-20
06953205995074Arm Type Automatic Blood Pressure MonitorBP367A2026-03-20
06953205995081Arm Type Automatic Blood Pressure MonitorBP313A2026-03-20
06953205995098Arm Type Automatic Blood Pressure MonitorBP351A2026-03-20
06953205995104Arm Type Automatic Blood Pressure MonitorBP362A2026-03-20
06953205995111Arm Type Automatic Blood Pressure MonitorBP366A2026-03-20
06953205995128Arm Type Automatic Blood Pressure MonitorBP369A2026-03-20
06953205995135Arm Type Automatic Blood Pressure MonitorBP380A2026-03-20
06953205995142Arm Type Automatic Blood Pressure MonitorBP389A2026-03-20
06953205900870Infrared ThermometerFR8202020-10-28
06953205900887Infrared ThermometerFR8102020-10-28
06953205900788Infrared ThermometerIFR6002018-07-03
06953205900795Infrared ThermometerIFR6102018-07-03
06953205900801Infrared ThermometerIFR6602018-07-03
06953205900818Infrared ThermometerFR8002018-07-23
06953205900832Infrared ThermometerFR8402018-07-23
06953205900849Infrared ThermometerFR8502018-07-23
06953205900856Infrared ThermometerFR8702018-07-23
06953205900863Infrared ThermometerFR8802018-07-23
06953205900016Arm Type Automatic Blood Pressure MonitorBP367A2018-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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08698870368867FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
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