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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 K844008
Device Name PENLON AM1000 ANAESTHESIA MACHINE
Applicant
Penlon, Inc.
Abingdon Ox 14 3ph
Abingdon Ox,  GB
Correspondent
Penlon, Inc.
Abingdon Ox 14 3ph
Abingdon Ox,  GB
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received10/12/1984
Decision Date 03/12/1985
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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