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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 K132205
Device Name ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
Applicant
INOVA LABS, INC.
2800 PLEASANT HILL RD., SUITE 175
SUITE 175
PLEASANT HILL,  CA  94523
Applicant Contact PAMELA M BUCKMAN
Correspondent
INOVA LABS, INC.
2800 PLEASANT HILL RD., SUITE 175
SUITE 175
PLEASANT HILL,  CA  94523
Correspondent Contact PAMELA M BUCKMAN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/16/2013
Decision Date 06/06/2014
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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