The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Hi-lo Temp Skin Temperature Sensor.
| Device ID | K821833 |
| 510k Number | K821833 |
| Device Name: | HI-LO TEMP SKIN TEMPERATURE SENSOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MALLINCKRODT CRITICAL CARE 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 | 1982-06-22 |
| Decision Date | 1982-07-20 |