The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Xenon Delivery System.
| Device ID | K820143 |
| 510k Number | K820143 |
| Device Name: | XENON DELIVERY SYSTEM |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Contact | Not Provided |
| Correspondent | Not Provided VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-19 |
| Decision Date | 1982-03-02 |