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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
Applicant
PAN-AMERICA HYPERBARICS, INC.
1510 PARK PLACE DRIVE
ATCHISON,  KS  66002
Applicant Contact WILLIAM M GATES, RRT
Correspondent
PAN-AMERICA HYPERBARICS, INC.
1510 PARK PLACE DRIVE
ATCHISON,  KS  66002
Correspondent 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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