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510(k) K862029

Device
SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT
Applicant
ELMED, INC.
510(k) number
K862029
Product code
IOA  
Decision
Substantially Equivalent (SESE)
Decision date
1986-07-16
Date received
1986-05-28
Regulation
890.5275
Classification name
Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KARL HAUSNER
Address
60 W. Fay Ave. Addison IL US 60101 60101

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IOA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K941567DIATHERMY DEVICE-MICROFOCUSCheung Laboratories, Inc.1996-04-22
K895000NEMECTRON MICROWAVENemectron Medical, Inc.1990-07-27
K860082THERMOTRON 918Medical Microwave Research Corp.1986-03-27

Legacy Summary#

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FDA Review#

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