FDA 510(k), K231820, SoloSmart Injection Pen Adapter (SoloSmart®)

510(K) Number: K231820
Device Name: SoloSmart Injection Pen Adapter (SoloSmart®)
Manufacturer: Alexia Garin
Device Classification Name: Injection Data Capture Device
Regulation Number: QOG
Classification Product Code: KXA
Date Received: 06/21/2023
Decision Date: 01/12/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital