The following data is part of a premarket notification filed by Televere Systems with the FDA for Televere Podiatry Digital Imaging System.
Device ID | K172124 |
510k Number | K172124 |
Device Name: | Televere Podiatry Digital Imaging System |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | Televere Systems 1160 Cavalier Rd Arnold, MD 21012 |
Contact | Randell Quaal |
Correspondent | Robert Bakin Technology And Business Law Advisors, LLC 1244 Capuchino Burlingame, CA 94010 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-14 |
Decision Date | 2017-11-09 |
Summary: | summary |