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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 K952316
Device Name NELLCOR SYMPHONY N-3000 PULSE OXIMETER
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 Number870.2700
Classification Product Code
DQA  
Date Received05/17/1995
Decision Date 08/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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