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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 K861987
Device Name 2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF
Applicant
OHMEDA MEDICAL
355 INVERNESS DR.SOUTH
ENGLEWOOD,  CO  80112 -5810
Applicant Contact DEANA DICKERSON
Correspondent
OHMEDA MEDICAL
355 INVERNESS DR.SOUTH
ENGLEWOOD,  CO  80112 -5810
Correspondent Contact DEANA DICKERSON
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/22/1986
Decision Date 02/03/1987
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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