The following data is part of a premarket notification filed by Infimed, Inc. with the FDA for Rtlx.
| Device ID | K992392 |
| 510k Number | K992392 |
| Device Name: | RTLX |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Contact | Ralph Flatau |
| Correspondent | Ralph Flatau INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-19 |
| Decision Date | 2000-03-31 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RTLX 75005179 2122131 Dead/Cancelled |
Panoramic Corporation 1995-10-13 |