The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Siemens Sonodynator 834, Ultrasound/stimulation.
| Device ID | K872909 |
| 510k Number | K872909 |
| Device Name: | SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Contact | Karl Hausner |
| Correspondent | Karl Hausner ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-24 |
| Decision Date | 1988-01-13 |