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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, Halothane, Gaseous-Phase (Anesthetic Conc.)
510(k) Number K896629
Device Name NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR
Applicant
Nellcor, Inc.
25495 Whitesell St.
Hayward,  CA  94545
Applicant Contact VIRGINIA PERRY
Correspondent
Nellcor, Inc.
25495 Whitesell St.
Hayward,  CA  94545
Correspondent Contact VIRGINIA PERRY
Regulation Number868.1620
Classification Product Code
CBS  
Date Received11/22/1989
Decision Date 02/12/1990
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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