PB-4 REPLAY UNIT

Recorder, Magnetic Tape, Medical

OXFORD MEDILOG, INC.

The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Pb-4 Replay Unit.

Pre-market Notification Details

Device IDK790289
510k NumberK790289
Device Name:PB-4 REPLAY UNIT
ClassificationRecorder, Magnetic Tape, Medical
Applicant OXFORD MEDILOG, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-02-08
Decision Date1979-02-27

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