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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K993220
Device Name PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
Applicant
Puritan Bennett Corp.
3 Missouri Research Park Dr.
St. Charles,  MO  63304
Applicant Contact TONY KEAVENEY
Correspondent
Puritan Bennett Corp.
3 Missouri Research Park Dr.
St. Charles,  MO  63304
Correspondent Contact TONY KEAVENEY
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received09/27/1999
Decision Date 10/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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