The following data is part of a premarket notification filed by Meridian Medical Systems, Llc with the FDA for Universal Digital Interface (udi) 1717.
| Device ID | K112527 |
| 510k Number | K112527 |
| Device Name: | UNIVERSAL DIGITAL INTERFACE (UDI) 1717 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | MERIDIAN MEDICAL SYSTEMS, LLC 325 HARRIS DRIVE Aurora, OH 44202 |
| Contact | Ariel Marciano |
| Correspondent | Ariel Marciano MERIDIAN MEDICAL SYSTEMS, LLC 325 HARRIS DRIVE Aurora, OH 44202 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-31 |
| Decision Date | 2012-05-22 |