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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 K011565
Device Name INFANT OXYGEN TREATMENT HOOD
Applicant
Gulf Coast Hyperbarics, Inc.
4309 Green Leaf Cir.
Panama City,  FL  32404
Applicant Contact JAMES W MCCARTHY
Correspondent
Gulf Coast Hyperbarics, Inc.
4309 Green Leaf Cir.
Panama City,  FL  32404
Correspondent Contact JAMES W MCCARTHY
Regulation Number868.5470
Classification Product Code
CBF  
Date Received05/21/2001
Decision Date 08/16/2001
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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