The following data is part of a premarket notification filed by Narco Air-shields with the FDA for Narco Air-sheilds Sys. 100 Monitor Sys.
| Device ID | K802800 |
| 510k Number | K802800 |
| Device Name: | NARCO AIR-SHEILDS SYS. 100 MONITOR SYS |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | NARCO AIR-SHIELDS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-06 |
| Decision Date | 1980-11-24 |