MEDILOG 4500 SYSTEM

Detector And Alarm, Arrhythmia

OXFORD MEDILOG, INC.

The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Medilog 4500 System.

Pre-market Notification Details

Device IDK860079
510k NumberK860079
Device Name:MEDILOG 4500 SYSTEM
ClassificationDetector And Alarm, Arrhythmia
Applicant OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater,  FL  33520
ContactMichael J Smith
CorrespondentMichael J Smith
OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater,  FL  33520
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-08
Decision Date1986-02-26

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