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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K963400
Device Name NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
Applicant
Nellcor Puritan Bennett, Inc.
11150 Thompson Ave.
Lenexa,  KS  66219
Applicant Contact DAVID A GREEN
Correspondent
Nellcor Puritan Bennett, Inc.
11150 Thompson Ave.
Lenexa,  KS  66219
Correspondent Contact DAVID A GREEN
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/29/1996
Decision Date 11/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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