The following data is part of a premarket notification filed by Medipart Jerry Alexander with the FDA for Medipart Xenon Breathing Kit Mp-02xm-i.
| Device ID | K850367 |
| 510k Number | K850367 |
| Device Name: | MEDIPART XENON BREATHING KIT MP-02XM-I |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
| Contact | Jerry A Alexander |
| Correspondent | Jerry A Alexander MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-30 |
| Decision Date | 1985-04-30 |