The following data is part of a premarket notification filed by Atc Medical Technology, Inc. with the FDA for Laser Backpointer Assembly, Mod. 01-2487.
| Device ID | K800489 |
| 510k Number | K800489 |
| Device Name: | LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | ATC MEDICAL TECHNOLOGY, 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 | 1980-03-04 |
| Decision Date | 1980-03-25 |