MODEL MR-45 AMBULATORY HOLTER MONITOR

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 Mr-45 Ambulatory Holter Monitor.

Pre-market Notification Details

Device IDK872497
510k NumberK872497
Device Name:MODEL MR-45 AMBULATORY HOLTER MONITOR
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 Received1987-06-24
Decision Date1987-10-06

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