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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 K945947
Device Name NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER
Applicant
Nellcor, Inc.
11150 Thompson Ave.
Lenexa,  KS  66219
Applicant Contact DAVID GREEN
Correspondent
Nellcor, Inc.
11150 Thompson Ave.
Lenexa,  KS  66219
Correspondent Contact DAVID GREEN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/06/1994
Decision Date 03/08/1995
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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