510(k) K200051
K200051 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "PUGGLE Enteral Feeding Pump and Feeding Set". The FDA issued a decision of Substantially Equivalent on September 25, 2020. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Amsino International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2020
- Date Received
- January 10, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Enteral
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type