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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, oxygen, gaseous-phase
510(k) Number K010318
Device Name PRIMA OXYGEN MONITOR
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 Number868.1720
Classification Product Code
CCL  
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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