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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 K870983
Device Name NOCTURNAL PENILE TUMESCENCE MONITOR
Applicant
Texas Medical Electronics Co.
P.O. Box 35725
Houston,  TX  77235
Applicant Contact HAYATI BALKANLI
Correspondent
Texas Medical Electronics Co.
P.O. Box 35725
Houston,  TX  77235
Correspondent Contact HAYATI BALKANLI
Classification Product Code
LIL  
Date Received03/10/1987
Decision Date 06/23/1987
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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