DIGITAL DIAGNOSTIC X-RAY SYSTEM

System, X-ray, Stationary

DRGEM CORPORATION

The following data is part of a premarket notification filed by Drgem Corporation with the FDA for Digital Diagnostic X-ray System.

Pre-market Notification Details

Device IDK102408
510k NumberK102408
Device Name:DIGITAL DIAGNOSTIC X-RAY SYSTEM
ClassificationSystem, X-ray, Stationary
Applicant DRGEM CORPORATION 77325 JOYCE WAY Ehco,  OR  97826
ContactCharlie Mack
CorrespondentCharlie Mack
DRGEM CORPORATION 77325 JOYCE WAY Ehco,  OR  97826
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-23
Decision Date2010-12-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800011140168 K102408 000
08800011140151 K102408 000
08800011140014 K102408 000
08800011140007 K102408 000

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