The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Dispos. Type T Thermocouple Temp.probe.
| Device ID | K830592 |
| 510k Number | K830592 |
| Device Name: | DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ELECTROMEDICS, 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 | 1983-02-24 |
| Decision Date | 1983-05-18 |