The following data is part of a premarket notification filed by Biotronex Laboratory, Inc. with the FDA for Temperature Monitor (w/probe).
| Device ID | K792257 |
| 510k Number | K792257 |
| Device Name: | TEMPERATURE MONITOR (W/PROBE) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | BIOTRONEX LABORATORY, INC. 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 | 1979-11-09 |
| Decision Date | 1979-12-04 |