FDA 510(k), K212217, Tempo Smart Button

FDA 510(k), K212217, Tempo Smart Button

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510(K) Number: K212217
Device Name: Tempo Smart Button
Manufacturer: Kevin S. Bardonner
Device Classification Name: Injection Data Capture Device
Regulation Number: QOG
Classification Product Code: 07/16/2021
Date Received: 09/16/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital

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