The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron 400.
Device ID | K924319 |
510k Number | K924319 |
Device Name: | DYNATRON 400 |
Classification | Interferential Current Therapy |
Applicant | DYNATRONICS CORP. 470 LAWNDALE DR. BUILDING D Salt Lake City, UT 84115 |
Contact | Robert J Cardon |
Correspondent | Robert J Cardon DYNATRONICS CORP. 470 LAWNDALE DR. BUILDING D Salt Lake City, UT 84115 |
Product Code | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-13 |
Decision Date | 1993-01-14 |