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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, oxygen, portable
510(k) Number K134023
Device Name 2300 SERIES MGO PORTABLE OXYGEN
Applicant
ULTRA ELECTRONICS LIMITED PRECISION AIR & LAND SY
ARLE COURT
HATHERLEY LANE
CHELTENHAM, GLOUCESTERSHIRE,  GB GL51 6PN
Applicant Contact ANDY CHILTON
Correspondent
ULTRA ELECTRONICS LIMITED PRECISION AIR & LAND SY
ARLE COURT
HATHERLEY LANE
CHELTENHAM, GLOUCESTERSHIRE,  GB GL51 6PN
Correspondent Contact ANDY CHILTON
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/30/2013
Decision Date 04/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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