FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets

K Number: K143263 · Decision May 29, 2015

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Classifications

FEI Numbers

Registration Numbers

Same Product Code

Applicant Total

130

Review Days

197

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Basic Information

Device Name: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K Number: K143263
Device Class: FDA class 2
Clearance Type: Traditional
Regulation Number: 880.5725
Medical Specialty: General Hospital
Decision: Substantially Equivalent
Statement or Summary: Summary
Applicant: Covidien
Date Received: November 13, 2014
Decision Date: May 29, 2015
Product Code: LZH
Advisory Committee: General Hospital
Review Advisory Committee: HO
Third Party: N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
LZH	Pump, Infusion, Enteral	FDA class 2	General Hospital

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