The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Radiation Exit Verification System/back Pointer System.
| Device ID | K934519 |
| 510k Number | K934519 |
| Device Name: | RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
| Contact | Donald Riibe |
| Correspondent | Donald Riibe MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
| Product Code | IWE |
| CFR Regulation Number | 892.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-17 |
| Decision Date | 1993-12-13 |