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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 K861605
Device Name SCHNEIDER-SHILEY PRESSURE MANOMETER
Applicant
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Applicant Contact MORTON BARAK
Correspondent
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Correspondent Contact MORTON BARAK
Regulation Number870.1140
Classification Product Code
KRK  
Date Received04/29/1986
Decision Date 05/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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