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Injection Data Capture Device

FDA product code QOG · 7 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5860
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-09-16 – 2025-08-28

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.

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