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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K922821
Device Name YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES
Applicant
YELLOW SPRINGS INSTRUMENT CO., INC.
1725 BRANNUM LN.
YELLOW SPRINGS,  OH  45387
Applicant Contact FRED BREIDT
Correspondent
YELLOW SPRINGS INSTRUMENT CO., INC.
1725 BRANNUM LN.
YELLOW SPRINGS,  OH  45387
Correspondent Contact FRED BREIDT
Regulation Number876.5130
Classification Product Code
EZL  
Date Received06/11/1992
Decision Date 11/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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