The following data is part of a premarket notification filed by Spectrum X-ray Corp. with the FDA for Spectrum Automatic Chest Unit Model C.
| Device ID | K791811 |
| 510k Number | K791811 |
| Device Name: | SPECTRUM AUTOMATIC CHEST UNIT MODEL C |
| Classification | Changer, Radiographic Film/cassette |
| Applicant | SPECTRUM X-RAY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPX |
| CFR Regulation Number | 892.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-18 |
| Decision Date | 1979-10-26 |