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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K031176
Device Name INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
Applicant
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA,  OH  44036 -2125
Applicant Contact RAE ANN FARROW
Correspondent
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA,  OH  44036 -2125
Correspondent Contact RAE ANN FARROW
Regulation Number868.5450
Classification Product Code
BTT  
Date Received04/14/2003
Decision Date 03/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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