The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (optional Accessory).
| Device ID | K031329 |
| 510k Number | K031329 |
| Device Name: | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Contact | Ron Hatch |
| Correspondent | Ron Hatch DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
| Product Code | IMI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | ILY |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-28 |
| Decision Date | 2003-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10660584000338 | K031329 | 000 |
| 10660584000192 | K031329 | 000 |
| 10660584000208 | K031329 | 000 |
| 10660584000345 | K031329 | 000 |
| 10660584000352 | K031329 | 000 |
| 10660584000369 | K031329 | 000 |
| 10660584000437 | K031329 | 000 |
| 10660584000017 | K031329 | 000 |
| 10660584000024 | K031329 | 000 |
| 10660584000031 | K031329 | 000 |
| 10660584000048 | K031329 | 000 |
| 10660584000055 | K031329 | 000 |
| 10660584000109 | K031329 | 000 |
| 10660584000116 | K031329 | 000 |
| 10660584000123 | K031329 | 000 |
| 10660584000130 | K031329 | 000 |
| 10660584000185 | K031329 | 000 |