The following data is part of a premarket notification filed by Narco Air-shields with the FDA for Probe Cover.
| Device ID | K810474 | 
| 510k Number | K810474 | 
| Device Name: | PROBE COVER | 
| Classification | Thermometer, Electronic, Clinical | 
| Applicant | NARCO AIR-SHIELDS 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | FLL | 
| CFR Regulation Number | 880.2910 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1981-02-23 | 
| Decision Date | 1981-03-31 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PROBE COVER  97750202  not registered Live/Pending | Zhou, Haiting 2023-01-11 |