510(k) K200051
- Device
- PUGGLE Enteral Feeding Pump And Feeding Set
- Applicant
- Amsino International Inc.
- 510(k) number
- K200051
- Product code
- LZH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-09-25
- Date received
- 2020-01-10
- Regulation
- 880.5725
- Classification name
- Pump, Infusion, Enteral
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jane Gao
- Address
- 708 Corporate Center Dr. Pomona CA US 91768 91768
FDA Registration Numbers#
- 1423537
- 9614277
- 3012169247
- 3000268902
- 3016705853
- 2183673
- 3005669815
- 3004906872
- 3008717264
- 3012341425
- 9610825
- 3013914978
- 3005700264
- 2029015
- 3007289408
- 1419562
- 3012337868
- 1921846
- 3005674464
- 3014637079
- 3031190571
- 3008058400
- 3009211636
- 3013764800
- 1722139
- 3014656668
- 1417592
- 3001124136
- 1416980
- 3011200334
- 9610849
- 3013788631
- 2011171
- 3012302888
- 3009247326
- 3012421607
- 9611018
- 9612030
- 3002879653
- 3037001242
Source Documents#
Other 510(k) Records For Product Code LZH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253558 | Luminoah FLOW™ Enteral Nutrition System | Luminoah | 2026-04-20 |
| K232205 | Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set | Vesco Medical, LLC | 2023-10-23 |
| K221603 | Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™ | Cardinal Health, LLC | 2022-12-20 |
| K220230 | AMSure Enteral Feeding Pump | Amsino International, Inc. | 2022-11-10 |
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal | Covidien | 2016-07-06 |
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | Covidien | 2015-05-29 |
| K141479 | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS | Covidien | 2014-12-23 |
| K131154 | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; | Zevex, Inc. | 2014-02-12 |
| K111381 | MEDI-SIS SYRINGE INFUSION SYSTEM | Acacia, Inc. | 2012-01-13 |
| K060316 | COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | Fresenius Kabi Deutschland GmbH | 2006-06-23 |
| K040957 | NOA III ENTERAL NUTRITION PUMP | Caesarea Medical Electronics , Ltd. | 2004-05-21 |
| K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | Tyco Healthcare/Kendall | 2004-05-05 |
| K031199 | ENTERALITE INFINITY ENTERAL FEEDING PUMP | Zevex Intl., Inc. | 2003-07-09 |
| K031407 | ROSS EMBRACE ENTERAL PUMP | Ross Product Div. Abbott Laboratories | 2003-05-20 |
| K011868 | ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS | Debio Tech SA | 2001-09-04 |
Legacy Summary#
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FDA Review#
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