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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.
MAHWAH,  NJ  07430 -0619
Applicant Contact KATHLEEN KRAMER
Correspondent
DATASCOPE CORP., PATIENT MONITORING DIVISION
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
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
Recalls CDRH Recalls
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