510(k) K230083
K230083 is an FDA 510(k) premarket notification submitted by Medovate Limited for the device "SAFIRA". The FDA issued a decision of Substantially Equivalent on October 31, 2023. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2023
- Date Received
- January 11, 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