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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K862376
Device Name NEMECTROSON MODEL 2
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 Number890.5290
Classification Product Code
IMJ  
Date Received06/24/1986
Decision Date 07/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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