The following data is part of a premarket notification filed by Meridian Medical Systems, Llc with the FDA for Universal Digital Interface 2w, Udi 2w.
| Device ID | K143232 |
| 510k Number | K143232 |
| Device Name: | Universal Digital Interface 2W, UDI 2W |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | MERIDIAN MEDICAL SYSTEMS, LLC 325 HARRIS DRIVE Aurora, OH 44202 |
| Contact | Larry Cornell |
| Correspondent | Larry Cornell MERIDIAN MEDICAL SYSTEMS, LLC 325 HARRIS DRIVE Aurora, OH 44202 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2015-01-30 |