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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Nitric Oxide Delivery
510(k) Number K000653
Device Name AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
Applicant
Pulmonox Medical Corp.
5243-53 Ave.
Tofield, Alberta,  CA T0B 4J0
Applicant Contact PAULA TOMAT
Correspondent
Pulmonox Medical Corp.
5243-53 Ave.
Tofield, Alberta,  CA T0B 4J0
Correspondent Contact PAULA TOMAT
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRO   MRP   MRQ  
Date Received02/28/2000
Decision Date 08/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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