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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 K833454
Device Name BIOREM 3000 & 4000
Applicant
Biorem
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Biorem
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LIL  
Date Received09/28/1983
Decision Date 02/21/1984
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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