The following data is part of a premarket notification filed by Medi Nuclear Corp., Inc. with the FDA for Model Xe-103 Xenon/master Ii.
| Device ID | K863996 |
| 510k Number | K863996 |
| Device Name: | MODEL XE-103 XENON/MASTER II |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | MEDI NUCLEAR CORP., INC. 4501 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Russell W King |
| Correspondent | Russell W King MEDI NUCLEAR CORP., INC. 4501 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-14 |
| Decision Date | 1986-11-04 |