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FDA 510(k)

ENTERALITE INFINITY ENTERAL FEEDING PUMP

K-Number: K031199 · 2003-07-09

ApplicantZevex Intl., Inc.
Decision Date2003-07-09
Product CodeLZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENTERALITE INFINITY ENTERAL FEEDING PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Zevex Intl., Inc.. It received FDA 510(k) clearance on 2003-07-09 under 510(k) number K031199. The device is classified under product code LZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERALITE INFINITY ENTERAL FEEDING PUMP?

ENTERALITE INFINITY ENTERAL FEEDING PUMP is a medical device that received FDA 510(k) clearance on 2003-07-09. The listed applicant is Zevex Intl., Inc.. The 510(k) number is K031199.

When did ENTERALITE INFINITY ENTERAL FEEDING PUMP receive FDA 510(k) clearance?

ENTERALITE INFINITY ENTERAL FEEDING PUMP received FDA 510(k) clearance on 2003-07-09, under 510(k) number K031199.

Who is the listed applicant for ENTERALITE INFINITY ENTERAL FEEDING PUMP?

The FDA 510(k) record lists Zevex Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTERALITE INFINITY ENTERAL FEEDING PUMP?

The FDA product code for ENTERALITE INFINITY ENTERAL FEEDING PUMP is LZH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Zevex Intl., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954735ENTERALITE

Related Devices (Code: LZH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoahK232205Vesco 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 SetVesco Medical, LLCK221603Kangaroo 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, LLCK220230AMSure Enteral Feeding PumpAmsino International, Inc.K200051PUGGLE Enteral Feeding Pump and Feeding SetAmsino International, Inc.K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalCovidien

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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