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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 K830221
Device Name BEDSIDE N.P.T. 9900 - PRINTER 9800
Applicant
Browne Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Browne Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LIL  
Date Received01/24/1983
Decision Date 03/17/1983
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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