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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 Dr.
Atchison,  KS  66002
Applicant Contact WILLIAM M GATES, RRT
Correspondent
Pan-America Hyperbarics, Inc.
1510 Park Place Dr.
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
Predetermined Change
Control Plan Authorized		 No
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