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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Penile Tumescence
510(k) Number K841202
Device Name DACOMED RIGISCAN SYSTEM
Applicant
Dacomed Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dacomed Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LIL  
Date Received03/21/1984
Decision Date 07/06/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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