The following data is part of a premarket notification filed by Mdi Consultants, Inc. with the FDA for Dfp4343c7.
| Device ID | K122589 |
| 510k Number | K122589 |
| Device Name: | DFP4343C7 |
| Classification | System, X-ray, Stationary |
| Applicant | MDI CONSULTANTS, INC. 55 NORTHERN BOULEVARD SUITE 200 Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah MDI CONSULTANTS, INC. 55 NORTHERN BOULEVARD SUITE 200 Great Neck, NY 11021 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-24 |
| Decision Date | 2012-10-05 |
| Summary: | summary |