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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 K771540
Device Name MAGNATHERM 2000
Applicant
Intl. Medical Electronics , Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Intl. Medical Electronics , Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received08/11/1977
Decision Date 10/04/1977
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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