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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 K925931
Device Name RT2 RIGIDITY AND TUMESCENCE TEST
Applicant
Compass Medical Technologies, Inc.
5005 Bryant Ave. S.
Suite 110
Minneapolis,  MN  55419
Applicant Contact PHILIP L BROOKS
Correspondent
Compass Medical Technologies, Inc.
5005 Bryant Ave. S.
Suite 110
Minneapolis,  MN  55419
Correspondent Contact PHILIP L BROOKS
Classification Product Code
LIL  
Date Received11/23/1992
Decision Date 12/21/1992
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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