DISETRONIC D-MODEM

Pump, Infusion

DISETRONIC MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic D-modem.

Pre-market Notification Details

Device IDK943952
510k NumberK943952
Device Name:DISETRONIC D-MODEM
ClassificationPump, Infusion
Applicant DISETRONIC MEDICAL SYSTEMS 5201 EAST RIVER RD. SUITE 312 Minneapolis,  MN  55421 -1014
ContactJames J Myers
CorrespondentJames J Myers
DISETRONIC MEDICAL SYSTEMS 5201 EAST RIVER RD. SUITE 312 Minneapolis,  MN  55421 -1014
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-15
Decision Date1995-10-07

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