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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K041057
Device Name FLO-RITE
Applicant
Ameriflo Corp.
478 Gradle Dr.
Carmel,  IN  46032
Applicant Contact MATTHEW THIE
Correspondent
Ameriflo Corp.
478 Gradle Dr.
Carmel,  IN  46032
Correspondent Contact MATTHEW THIE
Regulation Number868.5905
Classification Product Code
NFB  
Date Received04/23/2004
Decision Date 08/12/2004
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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