MODIFIED DR-2C/PMC 100

Recorder, Magnetic Tape, Medical

GENERAL DEVICES

The following data is part of a premarket notification filed by General Devices with the FDA for Modified Dr-2c/pmc 100.

Pre-market Notification Details

Device IDK896153
510k NumberK896153
Device Name:MODIFIED DR-2C/PMC 100
ClassificationRecorder, Magnetic Tape, Medical
Applicant GENERAL DEVICES 190 LEONIA AVE. Bogota,  NJ  07603
ContactMichael Smith
CorrespondentMichael Smith
GENERAL DEVICES 190 LEONIA AVE. Bogota,  NJ  07603
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-24
Decision Date1990-01-19

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