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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 K953472
Device Name NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR
Applicant
Nellcor, Inc.
4280 Hacienda Dr.
P.O. Box 8004
Pleasanton,  CA  94588
Applicant Contact MARSHA J STONE
Correspondent
Nellcor, Inc.
4280 Hacienda Dr.
P.O. Box 8004
Pleasanton,  CA  94588
Correspondent Contact MARSHA J STONE
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/24/1995
Decision Date 10/20/1995
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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