The following data is part of a premarket notification filed by Imed Systems & Consulting, Llc. with the FDA for Telepax.
| Device ID | K011173 |
| 510k Number | K011173 |
| Device Name: | TELEPAX |
| Classification | System, Image Processing, Radiological |
| Applicant | IMED SYSTEMS & CONSULTING, LLC. 4715 TRAIL COURT Westminster, MD 21158 |
| Contact | Kenneth P Bonner |
| Correspondent | Kenneth P Bonner IMED SYSTEMS & CONSULTING, LLC. 4715 TRAIL COURT Westminster, MD 21158 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-17 |
| Decision Date | 2001-07-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TELEPAX 77020062 3310543 Live/Registered |
Healthy-IT, LLC 2006-10-12 |
![]() TELEPAX 74461509 1884894 Dead/Cancelled |
SERTONS INTERNATIONAL B.V. 1993-11-12 |