DRY LASER IMAGER, DRYPRO MODEL 832

Camera, Multi Format, Radiological

KONICA MINOLTA MEDICAL & GRAPHIC, INC.

The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Dry Laser Imager, Drypro Model 832.

Pre-market Notification Details

Device IDK061999
510k NumberK061999
Device Name:DRY LASER IMAGER, DRYPRO MODEL 832
ClassificationCamera, Multi Format, Radiological
Applicant KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 ISHIKAWA-MACHI Hachioji-shi, Tokyo,  JP 192-8505
ContactJoji Matsushima
CorrespondentJoji Matsushima
KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 ISHIKAWA-MACHI Hachioji-shi, Tokyo,  JP 192-8505
Product CodeLMC  
CFR Regulation Number892.2040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-14
Decision Date2006-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560141922686 K061999 000
04560141921641 K061999 000

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