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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 K921526
Device Name DATASCOPE PASSPORT MONITOR WITH CO2
Applicant
Datascope Corp.
580 Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Applicant Contact MICHAEL BARILE
Correspondent
Datascope Corp.
580 Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Correspondent Contact MICHAEL BARILE
Regulation Number868.1400
Classification Product Code
CCK  
Date Received03/31/1992
Decision Date 10/14/1992
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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