The following data is part of a premarket notification filed by Medi Nuclear Corp., Inc. with the FDA for Medi/nuclear #xe-102 Xenon/master.
| Device ID | K810819 |
| 510k Number | K810819 |
| Device Name: | MEDI/NUCLEAR #XE-102 XENON/MASTER |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | MEDI NUCLEAR CORP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-24 |
| Decision Date | 1981-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857863007932 | K810819 | 000 |
| 00857863007390 | K810819 | 000 |