The following data is part of a premarket notification filed by Medical Knowledge Systems, Inc. with the FDA for Mks Beam Outline Projector.
| Device ID | K921876 |
| 510k Number | K921876 |
| Device Name: | MKS BEAM OUTLINE PROJECTOR |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | MEDICAL KNOWLEDGE SYSTEMS, INC. 3800 WOODWARD AVE. SUITE 900 Detroit, MI 48201 |
| Contact | Don P Ragan |
| Correspondent | Don P Ragan MEDICAL KNOWLEDGE SYSTEMS, INC. 3800 WOODWARD AVE. SUITE 900 Detroit, MI 48201 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-20 |
| Decision Date | 1992-06-25 |