The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Siemens Radiotherm 706, Microwave Therapy Unit.
| Device ID | K862029 |
| 510k Number | K862029 |
| Device Name: | SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT |
| Classification | Diathermy, Microwave, 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 | IOA |
| CFR Regulation Number | 890.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-28 |
| Decision Date | 1986-07-16 |