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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Uroflowmeter
510(k) Number K971913
Device Name GR100F URINE FLOWMETER
Applicant
ALBYN MEDICAL LTD.
BRIDGEND ROAD IND'L ESTATE
DINGWALL, ROSS-SHIRE,  GB IV15 9QF
Applicant Contact ROSS K MAXWELL
Correspondent
ALBYN MEDICAL LTD.
BRIDGEND ROAD IND'L ESTATE
DINGWALL, ROSS-SHIRE,  GB IV15 9QF
Correspondent Contact ROSS K MAXWELL
Regulation Number876.1800
Classification Product Code
EXY  
Date Received05/22/1997
Decision Date 09/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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