AMSure Enteral Feeding Pump

Pump, Infusion, Enteral

Amsino International Inc.

The following data is part of a premarket notification filed by Amsino International Inc. with the FDA for Amsure Enteral Feeding Pump.

Pre-market Notification Details

Device IDK220230
510k NumberK220230
Device Name:AMSure Enteral Feeding Pump
ClassificationPump, Infusion, Enteral
Applicant Amsino International Inc. 708 Corporate Center Drive Pomona,  CA  91768
ContactJane Gao
CorrespondentJane Gao
Amsino International Inc. 708 Corporate Center Drive Pomona,  CA  91768
Product CodeLZH  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-27
Decision Date2022-11-10

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