The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron 2000.
| Device ID | K880912 |
| 510k Number | K880912 |
| Device Name: | DYNATRON 2000 |
| Classification | Transducer, Miniature Pressure |
| Applicant | DYNATRONICS CORP. 470 LAWNDALE DR. BUILDING D Salt Lake City, UT 84115 |
| Contact | Steven R Woodhead |
| Correspondent | Steven R Woodhead DYNATRONICS CORP. 470 LAWNDALE DR. BUILDING D Salt Lake City, UT 84115 |
| Product Code | IKE |
| CFR Regulation Number | 890.1615 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-03 |
| Decision Date | 1988-03-15 |