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FDA 510(k), K230545, Inessa System
FDA 510(k), K230545, Inessa System
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510(K) Number: K230545
Device Name: Inessa System
Manufacturer: Triple Jump Israel Ltd.
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Regulation Number: 880.5730
Classification Product Code: QFG
Date Received: 02/28/2023
Decision Date: 12/20/2023
Regulation Medical Specialty: Clinical Chemistry
Device Name: Inessa System
Manufacturer: Triple Jump Israel Ltd.
Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Regulation Number: 880.5730
Classification Product Code: QFG
Date Received: 02/28/2023
Decision Date: 12/20/2023
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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