The following data is part of a premarket notification filed by Medical Alignment Systems with the FDA for Acculite Ssl.
| Device ID | K923619 |
| 510k Number | K923619 |
| Device Name: | ACCULITE SSL |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | MEDICAL ALIGNMENT SYSTEMS P.O. BOX 21433 3656 MACINTOSH LANE Salt Lake City, UT 84121 |
| Contact | George N Mcdonald |
| Correspondent | George N Mcdonald MEDICAL ALIGNMENT SYSTEMS P.O. BOX 21433 3656 MACINTOSH LANE Salt Lake City, UT 84121 |
| Product Code | IWE |
| CFR Regulation Number | 892.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1992-11-16 |