The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Bolus Xenon Circuit.
| Device ID | K912626 |
| 510k Number | K912626 |
| Device Name: | BOLUS XENON CIRCUIT |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Alberto Velez |
| Correspondent | Alberto Velez VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-13 |
| Decision Date | 1991-08-02 |