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 |