The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron 900.
Device ID | K993919 |
510k Number | K993919 |
Device Name: | DYNATRON 900 |
Classification | Equipment, Traction, Powered |
Applicant | DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
Contact | John S Ramsey |
Correspondent | John S Ramsey DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121 |
Product Code | ITH |
CFR Regulation Number | 890.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-18 |
Decision Date | 2000-01-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10660584000321 | K993919 | 000 |