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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 K881206
Device Name CHRONAMED CM101
Applicant
Chronamed Corp.
P.O. Box 2128
Lake Oswego,  OR  97035
Applicant Contact KATHLEEN SPIEKERMAN
Correspondent
Chronamed Corp.
P.O. Box 2128
Lake Oswego,  OR  97035
Correspondent Contact KATHLEEN SPIEKERMAN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received03/21/1988
Decision Date 12/05/1988
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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