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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K000512
Device Name OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
Applicant
Cas Medical Systems, Inc.
44 E. Industrial Rd.
Branford,  CT  06405
Applicant Contact RON JEFFREY
Correspondent
Cas Medical Systems, Inc.
44 E. Industrial Rd.
Branford,  CT  06405
Correspondent Contact RON JEFFREY
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received02/16/2000
Decision Date 09/26/2000
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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