The following data is part of a premarket notification filed by Swissray International, Inc. with the FDA for Digital Add On Multi System.
| Device ID | K973710 |
| 510k Number | K973710 |
| Device Name: | DIGITAL ADD ON MULTI SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | SWISSRAY INTERNATIONAL, INC. 121 METRO POLITAN DR. Liverpool, NY 13088 |
| Contact | Morteza Minaee |
| Correspondent | Morteza Minaee SWISSRAY INTERNATIONAL, INC. 121 METRO POLITAN DR. Liverpool, NY 13088 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-29 |
| Decision Date | 1997-12-18 |