MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING

Monitor, Breathing Frequency

OXFORD MEDILOG, INC.

The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Model 9000 Recording System/respiration Monitoring.

Pre-market Notification Details

Device IDK860455
510k NumberK860455
Device Name:MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING
ClassificationMonitor, Breathing Frequency
Applicant OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater,  FL  33520
ContactAlan P Schwartz
CorrespondentAlan P Schwartz
OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater,  FL  33520
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-05
Decision Date1986-04-01

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