MODEL 6000FD AMBULATORY ECG ANALYSIS 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 Model 6000fd Ambulatory Ecg Analysis System.

Pre-market Notification Details

Device IDK873680
510k NumberK873680
Device Name:MODEL 6000FD AMBULATORY ECG ANALYSIS 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 Received1987-09-14
Decision Date1987-11-23

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