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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K942347
Device Name NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000
Applicant
Nellcor, Inc.
11150 Thompson Ave.
Lenexa,  KS  66219
Applicant Contact DAVID A C. GREEN
Correspondent
Nellcor, Inc.
11150 Thompson Ave.
Lenexa,  KS  66219
Correspondent Contact DAVID A C. GREEN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/17/1994
Decision Date 05/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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