The following data is part of a premarket notification filed by Dynatronics Laser Corp. with the FDA for Dynatron 300 Ulrasound.
| Device ID | K920939 |
| 510k Number | K920939 |
| Device Name: | DYNATRON 300 ULRASOUND |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | DYNATRONICS LASER CORP. 470 LAWNDALE DRIVE, BUILDING D Salt Lake City, UT 84115 |
| Contact | Robert J Cardon |
| Correspondent | Robert J Cardon DYNATRONICS LASER CORP. 470 LAWNDALE DRIVE, BUILDING D Salt Lake City, UT 84115 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-27 |
| Decision Date | 1993-03-04 |