The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron 500.
Device ID | K870947 |
510k Number | K870947 |
Device Name: | DYNATRON 500 |
Classification | Stimulator, Muscle, Powered |
Applicant | DYNATRONICS CORP. C/O KING & SPALDING 1730 PENNSYLVANIA AVENUE, N.W. Washington, DC 20006 |
Contact | Jess H Stribling |
Correspondent | Jess H Stribling DYNATRONICS CORP. C/O KING & SPALDING 1730 PENNSYLVANIA AVENUE, N.W. Washington, DC 20006 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-09 |
Decision Date | 1987-08-18 |