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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manometer, Blood-Pressure, Venous
510(k) Number K950607
Device Name UST-5268P-5 TRANSDUCER
Applicant
Aloka Co., Ltd.
10 Fairfield Blvd.
Wallingford,  CT  06492
Applicant Contact PAUL D SMOLENSKI
Correspondent
Aloka Co., Ltd.
10 Fairfield Blvd.
Wallingford,  CT  06492
Correspondent Contact PAUL D SMOLENSKI
Regulation Number870.1140
Classification Product Code
KRK  
Date Received02/09/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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