The following data is part of a premarket notification filed by National Catheter Co. Div. Mallinckrodt with the FDA for Hi-lo Temp Gen. Purpose Temp. Probe.
| Device ID | K801924 |
| 510k Number | K801924 |
| Device Name: | HI-LO TEMP GEN. PURPOSE TEMP. PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | NATIONAL CATHETER CO. DIV. MALLINCKRODT 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 | 1980-08-12 |
| Decision Date | 1980-09-09 |