ALR Technologies SG Ltd (ALRTF)

[Neophius]

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102063

510(k) Premarket Notification

510(K) Number K102063
Device Name HEALTH-E-CONNECT SYSTEM
Applicant
ALR TECHNOLOGIES
24301 WOODSAGE DRIVE
Bonita Springs, FL 34134

Regulation Number 862.1345
Classification Product Code
NBW
Subsequent Product Code
JQP
Date Received 07/23/2010
Decision Date 10/11/2011
Decision Substantially Equivalent (SESE)

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.

That is all you can assume at this point. There's no demonstration of anything more.