Elite Biomedical Solutions Dose Request Cord

Accessories, Pump, Infusion

Elite Biomedical Solutions

The following data is part of a premarket notification filed by Elite Biomedical Solutions with the FDA for Elite Biomedical Solutions Dose Request Cord.

Pre-market Notification Details

Device IDK220695
510k NumberK220695
Device Name:Elite Biomedical Solutions Dose Request Cord
ClassificationAccessories, Pump, Infusion
Applicant Elite Biomedical Solutions 756 Cincinnati-Batavia Pike Suite C Cincinnati,  OH  45245
ContactBrenda Compliment
CorrespondentBrenda Compliment
Elite Biomedical Solutions 756 Cincinnati-Batavia Pike Suite C Cincinnati,  OH  45245
Product CodeMRZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-09
Decision Date2022-04-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860008635402 K220695 000

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