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FDA 510(k), K232380, t:slim X2 Insulin Pump with Interoperable Technology
FDA 510(k), K232380, t:slim X2 Insulin Pump with Interoperable Technology
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$49.00 USD
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$49.00 USD
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510(K) Number: K232380
Device Name: t:slim X2 Insulin Pump with Interoperable Technology
Manufacturer: Christin Dunn
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Regulation Number: QFG
Classification Product Code: KXA
Date Received: 08/08/2023
Decision Date: 11/03/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: t:slim X2 Insulin Pump with Interoperable Technology
Manufacturer: Christin Dunn
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Regulation Number: QFG
Classification Product Code: KXA
Date Received: 08/08/2023
Decision Date: 11/03/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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