MDR17 Mobile Direct Radiographic System

System, X-ray, Mobile

Del Medical, Inc.

The following data is part of a premarket notification filed by Del Medical, Inc. with the FDA for Mdr17 Mobile Direct Radiographic System.

Pre-market Notification Details

Device IDK173018
510k NumberK173018
Device Name:MDR17 Mobile Direct Radiographic System
ClassificationSystem, X-ray, Mobile
Applicant Del Medical, Inc. 241 Covington Dr. Bloomingdale,  IL  60108
ContactTony Bavuso
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-28
Decision Date2017-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858340006004 K173018 000

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