The following data is part of a premarket notification filed by American Medical Sales, Inc. with the FDA for Rotolux, Selectolux, Shuttervue.
| Device ID | K922079 |
| 510k Number | K922079 |
| Device Name: | ROTOLUX, SELECTOLUX, SHUTTERVUE |
| Classification | Illuminator, Radiographic-film |
| Applicant | AMERICAN MEDICAL SALES, INC. 8476 WARNER DR. Culver City, CA 90232 |
| Contact | Daniel J Giesberg |
| Correspondent | Daniel J Giesberg AMERICAN MEDICAL SALES, INC. 8476 WARNER DR. Culver City, CA 90232 |
| Product Code | IXC |
| CFR Regulation Number | 892.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1992-06-16 |