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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 K884158
Device Name THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER
Applicant
Ppg Industries, Inc.
9910 Widmer Dr.
Lenexa,  KS  66215
Applicant Contact JAMES F FERGUSON
Correspondent
Ppg Industries, Inc.
9910 Widmer Dr.
Lenexa,  KS  66215
Correspondent Contact JAMES F FERGUSON
Regulation Number868.1400
Classification Product Code
CCK  
Date Received10/04/1988
Decision Date 01/17/1989
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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