OTC DDR

System, X-ray, Stationary

Konica Minolta Healthcare Americas, Inc

The following data is part of a premarket notification filed by Konica Minolta Healthcare Americas, Inc with the FDA for Otc Ddr.

Pre-market Notification Details

Device IDK221853
510k NumberK221853
Device Name:OTC DDR
ClassificationSystem, X-ray, Stationary
Applicant Konica Minolta Healthcare Americas, Inc 2217 US Highway 70 East Garner,  NC  27529
ContactJan Maniscalco
CorrespondentJan Maniscalco
Konica Minolta Healthcare Americas, Inc 2217 US Highway 70 East Garner,  NC  27529
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-27
Decision Date2022-07-27

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.