The following data is part of a premarket notification filed by Advantech with the FDA for R-800-sf.
| Device ID | K904182 |
| 510k Number | K904182 |
| Device Name: | R-800-SF |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| Applicant | ADVANTECH 16 LAWRENCE ST. Wakefield, MA 01880 |
| Contact | Charles E Moreland |
| Correspondent | Charles E Moreland ADVANTECH 16 LAWRENCE ST. Wakefield, MA 01880 |
| Product Code | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-11 |
| Decision Date | 1990-11-13 |