The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Monaco Rtp System.
| Device ID | K110730 |
| 510k Number | K110730 |
| Device Name: | MONACO RTP SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 13723 RIVERPORT DR SUITE 100 Maryland Heights, MO 63043 |
| Contact | Kathryn Stinson |
| Correspondent | Kathryn Stinson COMPUTERIZED MEDICAL SYSTEMS, INC. 13723 RIVERPORT DR SUITE 100 Maryland Heights, MO 63043 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-16 |
| Decision Date | 2011-06-24 |
| Summary: | summary |