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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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