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510(k) Data Aggregation
K Number
K241803Device Name
INSULCLOCK® v2.0 PRO
Manufacturer
Insulcloud S.L.
Date Cleared
2024-08-22
(62 days)
Product Code
QOG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Insulcloud S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Insulclock® is for use by patients using disposable insulin diagnosed with type I or type II diabetes mellitus.
- Insulclock® is for use by people from 18 to 65 years old. Out of this age range, the Insulclock® must be used under supervision.
- Insulclock® is designed for use in any home environment.
- Using a compatible App.
INTENDED USE: INSULCLOCK® v2.0 pro is intended to detect, store and transfer insulin dose-related data, the time of injection and the temperature to which the disposable insulin pen has been exposed to. All this information is sent to a mobile app via integrated SDK.
Device Description
The INSULCLOCK® v2.0 pro is a reusable data transmitter with Software Development Kit (SDK) that detects and stores insulin dose- related data when attached to a disposable insulin pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology which can display the brand of insulin, dose amount, injection time, and ambient temperature.
Models:
- INSULCLOCK® v2.0 PRO for Kwikpen® (Lilly®)
- INSULCLOCK® v2.0 PRO for Flex-touch® (Novo Nordisk®)
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