The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Xenon Circuit.
| Device ID | K914747 |
| 510k Number | K914747 |
| Device Name: | XENON CIRCUIT |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-22 |
| Decision Date | 1992-02-27 |