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FDA 510(k)

ENTERALITE

K-Number: K954735 · 1996-04-15

ApplicantZevex Intl., Inc.
Decision Date1996-04-15
Product CodeLZH
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

ENTERALITE 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 1996-04-15 under 510(k) number K954735. The device is classified under product code LZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the ENTERALITE?

ENTERALITE is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Zevex Intl., Inc.. The 510(k) number is K954735.

When did ENTERALITE receive FDA 510(k) clearance?

ENTERALITE received FDA 510(k) clearance on 1996-04-15, under 510(k) number K954735.

Who is the listed applicant for ENTERALITE?

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?

The FDA product code for ENTERALITE 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.

K031199ENTERALITE INFINITY ENTERAL FEEDING PUMP

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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