The following data is part of a premarket notification filed by Del Medical, Inc. with the FDA for Mdr17 Mobile Direct Radiographic System.
Device ID | K173018 |
510k Number | K173018 |
Device Name: | MDR17 Mobile Direct Radiographic System |
Classification | System, X-ray, Mobile |
Applicant | Del Medical, Inc. 241 Covington Dr. Bloomingdale, IL 60108 |
Contact | Tony Bavuso |
Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-28 |
Decision Date | 2017-11-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858340006004 | K173018 | 000 |