Home / 510(k) Clearances / K231918

510(k) K231918

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter by Koru Medical Systems — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2023
Date Received
June 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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