MODEL 1010 AMBULATORY PH MONITORING SYSTEM

Electrode, Ph, Stomach

OXFORD MEDILOG, INC.

The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Model 1010 Ambulatory Ph Monitoring System.

Pre-market Notification Details

Device IDK862536
510k NumberK862536
Device Name:MODEL 1010 AMBULATORY PH MONITORING SYSTEM
ClassificationElectrode, Ph, Stomach
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 CodeFFT  
CFR Regulation Number876.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-02
Decision Date1986-09-12

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