The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Modulex Rtp System.
| Device ID | K913017 |
| 510k Number | K913017 |
| Device Name: | MODULEX RTP SYSTEM |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 56 WORTHINGTON DR. Maryland Heights, MO 63043 -3806 |
| Contact | Kim Ort |
| Correspondent | Kim Ort COMPUTERIZED MEDICAL SYSTEMS, INC. 56 WORTHINGTON DR. Maryland Heights, MO 63043 -3806 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-09 |
| Decision Date | 1991-10-17 |