The following data is part of a premarket notification filed by Dynatronics Corporation with the FDA for Dynatron Thermostim Probe-done.
| Device ID | K120835 |
| 510k Number | K120835 |
| Device Name: | DYNATRON THERMOSTIM PROBE-DONE |
| Classification | Electrode, Cutaneous |
| Applicant | DYNATRONICS CORPORATION 7030 PARK CENTRE DRIVE Salt Lake City, UT 84121 |
| Contact | Douglas Sampson |
| Correspondent | Douglas Sampson DYNATRONICS CORPORATION 7030 PARK CENTRE DRIVE Salt Lake City, UT 84121 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-20 |
| Decision Date | 2012-08-20 |
| Summary: | summary |