The following data is part of a premarket notification filed by Stardard X-ray Sales Co. with the FDA for Ox-600.
| Device ID | K920196 |
| 510k Number | K920196 |
| Device Name: | OX-600 |
| Classification | Changer, Radiographic Film/cassette |
| Applicant | STARDARD X-RAY SALES CO. 60 COIT ST. Irvington, NJ 07111 |
| Contact | Martin Weinberg |
| Correspondent | Martin Weinberg STARDARD X-RAY SALES CO. 60 COIT ST. Irvington, NJ 07111 |
| Product Code | KPX |
| CFR Regulation Number | 892.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-15 |
| Decision Date | 1992-10-14 |