510(k) K241803

INSULCLOCK® v2.0 PRO by Insulcloud S.L. — Product Code QOG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 22, 2024
Date Received: June 21, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Injection Data Capture Device
Device Class: Class II
Regulation Number: 880.5860
Review Panel: HO
Submission Type

An injection data capture device is an electrically-powered/electromechanical accessory that interfaces with reusable or disposable injection devices for the purposes of interpreting, recording and displaying and/or transmitting injection data to a connected application or software.

Other clearances for product code QOG

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K251500 — MallyaG Injection Pen Adapter (MallyaG) (June 9, 2025)
K250555 — MallyaD injection pen adapter (MallyaD) (March 27, 2025)
K231820 — SoloSmart Injection Pen Adapter (SoloSmart®) (January 12, 2024)
K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®) (December 5, 2022)
K212217 — Tempo Smart Button (September 16, 2022)