XXXXXMedicalTechnologyCO.,LtdCybersecurityDescriptiondocument
Productname:XXXX
Models:XXXX
Writtenby:Auditedby:Approvedby:
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Page1of7FileNo.:XXXVersion:1.0XXXXXMedicalTechnologyCO.,Ltd1.BasicinformationProductModename:XXXSoftwarename:bluetoothAPPCurrentversion：XXXHardwareorsoftwareplatform：SmartPhoneswithandroid4andabovesystemversion，XXXabove.Mainfunctions:“Bluetooth”APPcanstarttheXXXXtowork.;informationedit;CheckingordeletingthedataontheAPP...Programminglanguage:ClanguageOperatingsystem:SmartPhoneswithandroid4andabovesystemversion，XXXabove.OfftheShelfSoftware:NoOTSSoftwareProductModename:XXX
Softwarename:GPRSXXXHardwareorsoftwareplatform：SmartPhoneswithandroid4andabovesystemversion，XXXabove.Operatingsystem:SmartPhoneswithandroid4andabovesystemversion，XXXabove.OfftheShelfSoftware:NoOTSSoftwareProgramminglanguage:ClanguageMainfunctions:sendtheXXXdatatotheXXXwebpage....2.LevelofConcernDetermination
AccordingtoFDAGuidancedocument“GUIDANCEFORTHECONTENTOFPREMARKETSUBMISSIONSFORSOFTWARECONTAINEDINMEDICALDEVICES”,datedonMay11,2005,Determinationismadebasedtheanswertothefollowingquestions:Question1:DoestheSoftwareDevicequalifyasBloodEstablishmentComputerSoftware?Answer:NoQuestion2:IstheSoftwareDeviceintendedtobeusedincombinationwithadrugorbiologic?Answer:NoQuestion3:IstheSoftwareDeviceanaccessorytoamedicaldevicethathasaMajorLevelofConcern?Answer:NoQuestion4:DoestheSoftwareDevicecontrolalifesupportingorlifesustainingfunction?Answer:NoPage2of7FileNo.:XXXVersion:1.0
网络安全描述文档 Cybersecurity Description document (审核通过的)
