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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K010317
Device Name AV 800 VENTILATOR
Applicant
PENLON LTD.
RADLEY ROAD
ABINGDON
OXFORDSHIRE,  GB OX14 3PH
Applicant Contact ANTHONY PARSONS
Correspondent
PENLON LTD.
RADLEY ROAD
ABINGDON
OXFORDSHIRE,  GB OX14 3PH
Correspondent Contact ANTHONY PARSONS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/02/2001
Decision Date 07/23/2001
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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