The following data is part of a premarket notification filed by Meridian Medical Systems, Llc with the FDA for Universal Digital Interface 2, Udi 2.
| Device ID | K140251 |
| 510k Number | K140251 |
| Device Name: | UNIVERSAL DIGITAL INTERFACE 2, UDI 2 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-31 |
| Decision Date | 2014-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851354007036 | K140251 | 000 |
| 00851354007029 | K140251 | 000 |
| 00851354007012 | K140251 | 000 |
| 00851354007005 | K140251 | 000 |