The following data is part of a premarket notification filed by Dynatronics Laser Corp. with the FDA for Dynatron 350 Emg/biofeedback Analyzer.
| Device ID | K900639 |
| 510k Number | K900639 |
| Device Name: | DYNATRON 350 EMG/BIOFEEDBACK ANALYZER |
| Classification | Device, Biofeedback |
| Applicant | DYNATRONICS LASER CORP. 470 LAWNDALE DRIVE, BUILDING D Salt Lake City, UT 84115 |
| Contact | H Cullimore |
| Correspondent | H Cullimore DYNATRONICS LASER CORP. 470 LAWNDALE DRIVE, BUILDING D Salt Lake City, UT 84115 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-09 |
| Decision Date | 1990-10-04 |