PERSONAL MEDICATION INFUSER

Pump, Infusion

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Personal Medication Infuser.

Pre-market Notification Details

Device IDK810850
510k NumberK810850
Device Name:PERSONAL MEDICATION INFUSER
ClassificationPump, Infusion
Applicant PACESETTER SYSTEMS 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 Received1981-03-30
Decision Date1981-11-06

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