The following data is part of a premarket notification filed by Televere Systems, Inc. with the FDA for Televere Podiatry X-ray System Hf.
| Device ID | K180765 |
| 510k Number | K180765 |
| Device Name: | Televere Podiatry X-Ray System HF |
| Classification | System, X-ray, Stationary |
| Applicant | Televere Systems, Inc. Arnold, MD 21012 |
| Contact | Randell Quaal |
| Correspondent | Robert Bakin Technology And Business Law Advisors, LLC 1244 Capucruno Burlingame, CA 94010 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-23 |
| Decision Date | 2018-04-20 |
| Summary: | summary |