PUGGLE Enteral Feeding Pump and Feeding Set— 510(k) K200051
Substantially EquivalentAmsino International, Inc.
FDA 510(k) clearance K200051 for PUGGLE Enteral Feeding Pump and Feeding Set, Substantially Equivalent on 2020-09-25. Applicant: Amsino International, Inc.. Device class: 2.
Clearance details
- Applicant
- Amsino International, Inc.
- Product code
- Code LZH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pomona, CA, US
Recent devices under product code LZH
view all- K253558 — Luminoah FLOW Enteral Nutrition System
- K232205 — Vesco Q Enteral Feeding Pump +4 more
- K221603 — Kangaroo OMNI Enteral Feeding Pump (385400 ) +9 more
- K220230 — AMSure Enteral Feeding Pump
- K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
More clearances from Amsino International, Inc.
view all- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K220267 — AMSafe NeuFlo Needleless Connector
- K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe
- K183473 — AMSafe(R) Pre-Filled Normal Saline Flush Syringe
- K181445 — AMSure Hydrophilic Intermittent Catheter
Adverse events under product code LZH
product code LZH- Death
- 12
- Malfunction
- 4,186
- Total
- 4,198
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.