EVENT TAPE RECORDER 8293

Recorder, Magnetic Tape, Medical

AEQUITRON MEDICAL, INC.

The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Event Tape Recorder 8293.

Pre-market Notification Details

Device IDK833349
510k NumberK833349
Device Name:EVENT TAPE RECORDER 8293
ClassificationRecorder, Magnetic Tape, Medical
Applicant AEQUITRON MEDICAL, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-27
Decision Date1984-04-17

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