BETA I PROGRAMMABLE INFUSION PUMP

Pump, Infusion

ORANGE MEDICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Orange Medical Instruments, Inc. with the FDA for Beta I Programmable Infusion Pump.

Pre-market Notification Details

Device IDK831897
510k NumberK831897
Device Name:BETA I PROGRAMMABLE INFUSION PUMP
ClassificationPump, Infusion
Applicant ORANGE MEDICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-14
Decision Date1983-08-12

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