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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 K173147
Device Name SuperNO2VA Et Device
Applicant
Revolutionary Medical Devices, Inc.
4090 E Bujia Primera
Tucson,  AZ  85718
Applicant Contact David M. Kane
Correspondent
ProMedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
BSJ  
Date Received09/29/2017
Decision Date 06/20/2018
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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