FDA 510(k) Applications for Medical Device Product Code "LZH"
(Pump, Infusion, Enteral)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K111381 | ACACIA, INC. | MEDI-SIS SYRINGE INFUSION SYSTEM | 01/13/2012 |
| K220230 | Amsino International Inc. | AMSure Enteral Feeding Pump | 11/10/2022 |
| K200051 | Amsino International Inc. | PUGGLE Enteral Feeding Pump and Feeding Set | 09/25/2020 |
| K040957 | CAESAREA MEDICAL ELECTRONICS LTD. | NOA III ENTERAL NUTRITION PUMP | 05/21/2004 |
| K221603 | Cardinal Health LLC | Kangaroo OMNIÖ Enteral Feeding Pump (385400 );Kangaroo OMNIÖ Feeding Set 500ml (B5FD );Kangaroo OMNIÖ ENtelliSet 500ml (E5FD );Kangaroo OMNIÖ Feeding Set 1000ml (B10FD );Kangaroo OMNIÖ ENtelliSet 1000ml (E10FD );Kangaroo OMNIÖ ENPlus Spike Set (BSPFD ) | 12/20/2022 |
| K143263 | COVIDIEN | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | 05/29/2015 |
| K153074 | COVIDIEN | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal | 07/06/2016 |
| K141479 | COVIDIEN | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS | 12/23/2014 |
| K011868 | DEBIOTECH S.A. | ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS | 09/04/2001 |
| K011587 | ENTRACON CORP. | SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP | 06/01/2001 |
| K981541 | FRANTZ MEDICAL DEVELOPMENT, LTD. | CLEARSTAR ENTERAL NUTRITION PUMP | 08/13/1998 |
| K060316 | FRESENIUS KABI DEUTSCHLAND GMBH | COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS | 06/23/2006 |
| K946168 | IVAC CORPORATION | IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS | 03/21/1996 |
| K003047 | ROSS PRODUCT DIV. ABBOTT LABORATORIES | AMBULATORY ENTERAL NUTRITION PUMP | 06/12/2001 |
| K031407 | ROSS PRODUCT DIV. ABBOTT LABORATORIES | ROSS EMBRACE ENTERAL PUMP | 05/20/2003 |
| K040196 | TYCO HEALTHCARE/KENDALL | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | 05/05/2004 |
| K232205 | Vesco Medical, LLC | Vesco QÖ Enteral Feeding Pump; Vesco QÖ 500mL Bag Feed Set; Vesco QÖ 1000mL Bag Feed Set; Vesco QÖ 40mm Screw Cap Feed Set; Vesco QÖ ENPlus Feed Set | 10/23/2023 |
| K954735 | ZEVEX INTL., INC. | ENTERALITE | 04/15/1996 |
| K031199 | ZEVEX INTL., INC. | ENTERALITE INFINITY ENTERAL FEEDING PUMP | 07/09/2003 |
| K131154 | ZEVEX, INC. | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; | 02/12/2014 |
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