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 |