The following data is part of a premarket notification filed by Dynatronics Laser Corp. with the FDA for Dynatron Ii.
| Device ID | K880464 |
| 510k Number | K880464 |
| Device Name: | DYNATRON II |
| Classification | Dynamometer, Ac-powered |
| Applicant | DYNATRONICS LASER CORP. 470 LAWNDALE DRIVE, BUILDING D Salt Lake City, UT 84115 |
| Contact | Steven R Woodhead |
| Correspondent | Steven R Woodhead DYNATRONICS LASER CORP. 470 LAWNDALE DRIVE, BUILDING D Salt Lake City, UT 84115 |
| Product Code | LBB |
| CFR Regulation Number | 888.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-03 |
| Decision Date | 1988-03-08 |