The following data is part of a premarket notification filed by Williams Healthcare Systems, Llc. with the FDA for Intertron 6000/6100.
| Device ID | K930186 |
| 510k Number | K930186 |
| Device Name: | INTERTRON 6000/6100 |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | WILLIAMS HEALTHCARE SYSTEMS, LLC. 14833 WEST 95TH ST. Lenexa, KS 66215 |
| Contact | Craig Seyl |
| Correspondent | Craig Seyl WILLIAMS HEALTHCARE SYSTEMS, LLC. 14833 WEST 95TH ST. Lenexa, KS 66215 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-14 |
| Decision Date | 1993-07-02 |