The following data is part of a premarket notification filed by Focused Viewer, Inc. with the FDA for Diffuser Panel.
| Device ID | K970240 |
| 510k Number | K970240 |
| Device Name: | DIFFUSER PANEL |
| Classification | Illuminator, Radiographic-film |
| Applicant | FOCUSED VIEWER, INC. 2420 PASADENA BLVD. Wauwatosa, WI 53226 |
| Contact | William Brauer, M.d. |
| Correspondent | William Brauer, M.d. FOCUSED VIEWER, INC. 2420 PASADENA BLVD. Wauwatosa, WI 53226 |
| Product Code | IXC |
| CFR Regulation Number | 892.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-22 |
| Decision Date | 1997-03-11 |
| Summary: | summary |