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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 K915699
Device Name NELLCOR PORTABLE PULSE OXIMETER MODEL N-20
Applicant
Nellcor, Inc.
25495 Whitesell St.
Hayward,  CA  94545
Applicant Contact KENNETH MICHAEL
Correspondent
Nellcor, Inc.
25495 Whitesell St.
Hayward,  CA  94545
Correspondent Contact KENNETH MICHAEL
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/23/1991
Decision Date 05/27/1993
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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