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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 K863784
Device Name NELLCOR N-200 (PULSE OXIMETER)
Applicant
Nellcor, Inc.
25495 Whitesell St.
Hayward,  CA  94545
Applicant Contact BARBARA J BLACK
Correspondent
Nellcor, Inc.
25495 Whitesell St.
Hayward,  CA  94545
Correspondent Contact BARBARA J BLACK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/26/1986
Decision Date 11/21/1986
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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