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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 K123211
Device Name A5 ANESTHESIA DELIVERY SYSTEM
Applicant
DATASCOPE CORP., PATIENT MONITORING DIVISION
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Applicant Contact RUSSELL OLSEN
Correspondent
DATASCOPE CORP., PATIENT MONITORING DIVISION
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Correspondent Contact RUSSELL OLSEN
Regulation Number868.5160
Classification Product Code
BSZ  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   CCL  
NHO   NHP   NHQ  
Date Received10/12/2012
Decision Date 02/14/2013
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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