The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Temprobe Monitor.
| Device ID | K840648 |
| 510k Number | K840648 |
| Device Name: | TEMPROBE MONITOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | VITAL SIGNS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-15 |
| Decision Date | 1984-06-05 |