The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Xenon Xe 127/xe 133 Gas Dispenser.
| Device ID | K843640 |
| 510k Number | K843640 |
| Device Name: | XENON XE 127/XE 133 GAS DISPENSER |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | MALLINCKRODT CRITICAL CARE P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Thomas W Tusing |
| Correspondent | Katie Merkel MALLINCKRODT CRITICAL CARE P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1985-01-14 |