MODIFICATION TO GAMMA GUIDANCE SYSTEM

Probe, Uptake, Nuclear

RADIATION MONITORING DEVICES, INC.

The following data is part of a premarket notification filed by Radiation Monitoring Devices, Inc. with the FDA for Modification To Gamma Guidance System.

Pre-market Notification Details

Device IDK983768
510k NumberK983768
Device Name:MODIFICATION TO GAMMA GUIDANCE SYSTEM
ClassificationProbe, Uptake, Nuclear
Applicant RADIATION MONITORING DEVICES, INC. 44 HUNT ST. Watertown,  MA  02472 -4699
ContactPaul Stoppel
CorrespondentPaul Stoppel
RADIATION MONITORING DEVICES, INC. 44 HUNT ST. Watertown,  MA  02472 -4699
Product CodeIZD  
CFR Regulation Number892.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-26
Decision Date1999-07-02
Summary:summary

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