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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 K911310
Device Name COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD
Applicant
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Applicant Contact BRIAN R BARRY
Correspondent
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Correspondent Contact BRIAN R BARRY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/18/1991
Decision Date 06/10/1991
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
Recalls CDRH Recalls
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