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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K121167
Device Name CAIRE COMPANION 5 OXYGEN CONCENTRATOR
Applicant
Caire, Inc.
2200 Airport Industrial Dr., Suite 500
Ball Ground,  GA  30107
Applicant Contact BEN KADRLIK
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact PAULA WILKERSON
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/17/2012
Decision Date 05/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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