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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K080175
Device Name NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
Applicant
Datascope Corp., Patient Monitoring Division
800 Macarthur Blvd.
Mahwh,  NJ  07430
Applicant Contact KATHLEEN KRAMER
Correspondent
Datascope Corp., Patient Monitoring Division
800 Macarthur Blvd.
Mahwh,  NJ  07430
Correspondent Contact KATHLEEN KRAMER
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received01/24/2008
Decision Date 06/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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