The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron 200 Microcurrent.
Device ID | K903577 |
510k Number | K903577 |
Device Name: | DYNATRON 200 MICROCURRENT |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | DYNATRONICS CORP. 470 LAWNDALE DR. BUILDING D Salt Lake City, UT 84115 |
Contact | Robert Cardon |
Correspondent | Robert Cardon DYNATRONICS CORP. 470 LAWNDALE DR. BUILDING D Salt Lake City, UT 84115 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-08 |
Decision Date | 1991-03-15 |