The following data is part of a premarket notification filed by Radkor, Inc. with the FDA for Radkor Sfc-21.
| Device ID | K881701 |
| 510k Number | K881701 |
| Device Name: | RADKOR SFC-21 |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
| Contact | Jack E Briggs |
| Correspondent | Jack E Briggs RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-19 |
| Decision Date | 1988-09-08 |