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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K982135
Device Name OSCILLOMATE EMS NIBP MONITOR MODEL 9001
Applicant
Cas Medical Systems, Inc.
21 Business Park Dr.
Branford,  CT  06405
Applicant Contact RON JEFFREY
Correspondent
Cas Medical Systems, Inc.
21 Business Park Dr.
Branford,  CT  06405
Correspondent Contact RON JEFFREY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/17/1998
Decision Date 09/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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