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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K915494
Device Name NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60
Applicant
Nellcor, Inc.
25495 Whitesell St.
Hayward,  CA  94545
Applicant Contact KENNETH R MICHAEL
Correspondent
Nellcor, Inc.
25495 Whitesell St.
Hayward,  CA  94545
Correspondent Contact KENNETH R MICHAEL
Regulation Number868.1400
Classification Product Code
CCK  
Date Received12/09/1991
Decision Date 08/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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