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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, carbon-dioxide, gaseous-phase
510(k) Number K162343
Device Name Westmed Gas Sampling Cannula with O2 delivery
Applicant
WESTMED, INC.
5580 S NOGALES HWY
TUCSON,  AZ  85706
Applicant Contact DIANA UPP
Correspondent
WESTMED, INC.
5580 S NOGALES HWY
TUCSON,  AZ  85706
Correspondent Contact PAUL DRYDEN
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
CAT  
Date Received08/22/2016
Decision Date 12/14/2016
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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