EV APAN DIGITAL, MODEL K1VSM2000

System, X-ray, Extraoral Source, Digital

AFP IMAGING CORP.

The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Ev Apan Digital, Model K1vsm2000.

Pre-market Notification Details

Device IDK041120
510k NumberK041120
Device Name:EV APAN DIGITAL, MODEL K1VSM2000
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford,  NY  10523
ContactJames Johnson
CorrespondentJames Johnson
AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford,  NY  10523
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-29
Decision Date2004-08-30
Summary:summary

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