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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K040145
Device Name ATA HCM MONOPLACE HYPERBARIC SYSTEM
Applicant
Ata Hyperbaric Chamber Manufacturing
695-Alpha St.
Victoria, Bc,  CA
Applicant Contact HUMPHREY KILLAM
Correspondent
Ata Hyperbaric Chamber Manufacturing
695-Alpha St.
Victoria, Bc,  CA
Correspondent Contact HUMPHREY KILLAM
Regulation Number868.5470
Classification Product Code
CBF  
Date Received01/22/2004
Decision Date 05/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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