DR-2C (MODIFICATION)

Recorder, Paper Chart

GENERAL DEVICES

The following data is part of a premarket notification filed by General Devices with the FDA for Dr-2c (modification).

Pre-market Notification Details

Device IDK862596
510k NumberK862596
Device Name:DR-2C (MODIFICATION)
ClassificationRecorder, Paper Chart
Applicant GENERAL DEVICES 86 HARRIET AVE. Bergenfield,  NJ  07621
ContactMichael Smith
CorrespondentMichael Smith
GENERAL DEVICES 86 HARRIET AVE. Bergenfield,  NJ  07621
Product CodeDSF  
CFR Regulation Number870.2810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-27
Decision Date1986-09-26

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