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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 K852175
Device Name PATIENT DATA SYSTEMS CVA
Applicant
Patient Data Systems
761 Boston Post Rd.
Weston,  MA  02193
Applicant Contact MONTEJO
Correspondent
Patient Data Systems
761 Boston Post Rd.
Weston,  MA  02193
Correspondent Contact MONTEJO
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received05/20/1985
Decision Date 09/06/1985
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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