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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Miniature Pressure
510(k) Number K954670
Device Name PRESSORE MONITOR
Applicant
Cleveland Medical Devices, Inc.
11000 Cedar Ave.
Suite 439
Cleveland,  OH  44106
Applicant Contact ROBERT N SCHMIDT
Correspondent
Cleveland Medical Devices, Inc.
11000 Cedar Ave.
Suite 439
Cleveland,  OH  44106
Correspondent Contact ROBERT N SCHMIDT
Regulation Number890.1615
Classification Product Code
IKE  
Date Received10/10/1995
Decision Date 10/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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