The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Wall Mounted Laser Positioning Device.
| Device ID | K801541 |
| 510k Number | K801541 |
| Device Name: | WALL MOUNTED LASER POSITIONING DEVICE |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IWE |
| CFR Regulation Number | 892.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-03 |
| Decision Date | 1980-08-20 |