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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, continuous, facility use
510(k) Number K122560
Device Name VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
Original Applicant
PAN-AMERICA HYPERBARICS, INC.
1510 park place drive
atchison,  KS  66002
Original Contact william m gates, rrt
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/22/2012
Decision Date 03/26/2013
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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