The following data is part of a premarket notification filed by Meridian Medical Systems, Llc with the FDA for Paragon 2.
| Device ID | K162687 |
| 510k Number | K162687 |
| Device Name: | Paragon 2 |
| Classification | System, X-ray, Mobile |
| Applicant | MERIDIAN MEDICAL SYSTEMS, LLC 325 HARRIS DRIVE Aurora, OH 44202 7539 |
| Contact | Larry Cornell |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-27 |
| Decision Date | 2016-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851354007159 | K162687 | 000 |