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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 K844256
Device Name NELLCOR PULSE OXIMETER N-10
Applicant
NELLCOR, INC.
25495 WHITESELL ST.
HAYWARD,  CA  94545
Applicant Contact MARCIA K ALLEN
Correspondent
NELLCOR, INC.
25495 WHITESELL ST.
HAYWARD,  CA  94545
Correspondent Contact MARCIA K ALLEN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/02/1984
Decision Date 12/27/1984
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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