FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS

K Number: K060316 · Decision Jun 23, 2006
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
33
Applicant Total
1
Review Days
135

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Basic Information

Device Name
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K Number
K060316
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5725
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Fresenius Kabi Deutschland GmbH
Date Received
February 8, 2006
Decision Date
June 23, 2006
Product Code
LZH
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
Y

Classifications

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

Product Code Device Name
LZH Pump, Infusion, Enteral

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