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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 K855022
Device Name COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK
Applicant
COMPUTERIZED ANESTHESIA SYSTEMS, INC.
2310 VALLEY WOOD DR.
P.O. BOX 13349
AKRON,  OH  44313
Applicant Contact MARK CRAWFORD
Correspondent
COMPUTERIZED ANESTHESIA SYSTEMS, INC.
2310 VALLEY WOOD DR.
P.O. BOX 13349
AKRON,  OH  44313
Correspondent Contact MARK CRAWFORD
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received12/16/1985
Decision Date 02/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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