FDA 510(k), K223846, iLet® ACE Pump

FDA 510(k), K223846, iLet® ACE Pump

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510(K) Number: K223846
Device Name: iLet® ACE Pump
Manufacturer: Vikram Verma
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Regulation Number: QFG
Classification Product Code: KXA
Date Received: 12/20/2022
Decision Date: 05/19/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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