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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 K780755
Device Name SHORTWAVE DIATHERMY MODEL 802
Applicant
Birtcher Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Birtcher Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received05/08/1978
Decision Date 05/12/1978
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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