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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K895000
Device Name NEMECTRON MICROWAVE
Applicant
NEMECTRON MEDICAL, INC.
28069 DIAZ RD., UNIT A
TEMECULA,  CA  92590
Applicant Contact JUERGEN F KOPF
Correspondent
NEMECTRON MEDICAL, INC.
28069 DIAZ RD., UNIT A
TEMECULA,  CA  92590
Correspondent Contact JUERGEN F KOPF
Regulation Number890.5275
Classification Product Code
IOA  
Date Received08/08/1989
Decision Date 07/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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