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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
Predetermined Change
Control Plan Authorized		 No
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