Koru Medical Freedom60 Infusion Pump judged ‘Substantially Equivalent’ by FDA

Koru Medical Systems’ Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; and Freedom60 Pre-Filled Syringe Adapter were decided by the FDA to be “Substantially Equivalent” according to a 510(k) Premarket Notification with a decision date of November 3 posted to the agency’s website.